Karuna Therapeutics CFO sells $3.44M in common stock » 19:4310/0410/04/22
In a regulatory filing,…
In a regulatory filing, Karuna Therapeutics disclosed that its CFO Troy Ignelzi sold 15K shares of common stock on September 30th in a total transaction size of $3.44M.
Biohaven launches as a new publicly traded company » 07:3910/0410/04/22
BHVN, PFE, ALNY, BMY
Biohaven (BHVN) launched…
Biohaven (BHVN) launched as a new publicly traded company. As of today, Biohaven has officially begun operating as a separate independent entity as part of the acquisition agreement with Pfizer (PFE) in May 2022. The company, led by Vlad Coric, M.D. as Chairman and Chief Executive Officer, launched with approximately $257.8 million in cash at the distribution and no debt. Biohaven has a history of successful drug development and commercialization. The FDA filed and accepted for review Biohaven's New Drug Application submission for zavegepant nasal spray with a Prescription Drug User Fee Act goal date set for the first quarter of 2023. With the acquisition by Pfizer for a total consideration of approximately $13B including payoff of existing debt, Pfizer will now exclusively commercialize and develop the Biohaven CGRP franchise globally. Pfizer owns approximately 3% of the new spinoff company Biohaven. Advancing a Broad Portfolio of Innovative Candidates: Biohaven plans to advance a broad portfolio of early- and late-stage innovative product candidates targeting neurological and neuropsychiatric diseases, including rare disorders with unmet medical needs. Therapeutic development will focus on treatments for epilepsy, pain and mood disorders, obsessive compulsive disorder, spinocerebellar ataxia and spinal muscular atrophy. Key clinical development programs underway that leverage these proprietary technology platforms, include the following: Glutamate modulation for SCA and OCD; Myostatin inhibition for neuromuscular diseases, and potentially for diabetes and weight loss; Novel immune modulation platform targeting CD-38 for multiple myeloma Team executives: The Biohaven Board of Directors remains the same. Irfan Qureshi, M.D. is promoted to Chief Medical Officer, previously Senior Vice President of Neurology at Biohaven. And Tanya Fischer, M.D., Ph.D. is appointed Chief Development Officer and Head of Translational Medicine, previously at Alnylam Pharmaceuticals (ALNY). Bruce Car, Ph.D. joins Biohaven as the new Chief Scientific Officer. Dr. Car brings more than 28 years of experience in the pharmaceutical industry having held numerous scientific leadership positions at Bristol-Myers Squibb (BMY).
Voyager announces Pfizer exercises option to license novel capsid » 07:1310/0410/04/22
Voyager Therapeutics (VYGR) announced that Pfizer (PFE) has exercised its option to license a novel capsid generated from Voyager's TRACER capsid discovery platform to help enable a potential gene therapy program against an undisclosed rare neurologic disease target. Under the terms of the license option agreement, originally announced in October 2021, Voyager previously received a $30 million upfront payment and is entitled to receive a $10 million option exercise payment. Voyager is eligible to receive potential future development, regulatory and commercialization milestone payments of up to $115 million, sales milestones of up to $175 million, and mid- to high-single-digit tiered royalties in connection with Pfizer's use of its capsid in development and commercialization of a gene therapy for a rare neurologic target. The target under agreement with Pfizer is distinct from those utilized in Voyager's internal pipeline programs. Pfizer has elected not to exercise its option to license a capsid for the cardiac target under the original agreement, and all capsid rights for that target are returned to Voyager. Voyager retains global rights to all licensed capsids for use with other transgenes and to all other applications of its TRACER technology.
Pfizer announces Phase 3 TALAPRO-2 trial meets primary endpoint » 06:4710/0410/04/22
Pfizer announced topline…
Pfizer announced topline results from the Phase 3 TALAPRO-2 study of TALZENNA, an oral poly ADP-ribose polymerase inhibitor, in combination with XTANDI compared to placebo plus XTANDI in men with metastatic castration-resistant prostate cancer with or without homologous recombination repair gene mutations. The study met its primary endpoint with a statistically significant and clinically meaningful improvement in radiographic progression-free survival compared with placebo plus XTANDI. The results of the primary endpoint exceeded the pre-specified hazard ratio of 0.696. Results showed a trend toward improved overall survival, a key secondary endpoint, at the time of the analysis, but these data are not yet mature. Benefits were also observed in other secondary endpoints, including investigator assessed rPFS, prostate specific antigen response, time to PSA progression, and overall response rate. Other secondary endpoints are being analyzed. At the time of topline analysis, the safety of TALZENNA plus XTANDI were generally consistent with the known safety profile of each medicine. Detailed results from TALAPRO-2 will be submitted for presentation at a near-term medical congress. These data will also be shared with global regulatory authorities to potentially support a regulatory filing. TALZENNA or the combination of TALZENNA plus XTANDI have not been approved by any regulatory agency for the treatment of mCRPC. In addition to the TALAPRO-2 trial, the combination of TALZENNA plus XTANDI is being investigated in the TALAPRO-3 trial, a global, randomized, double-blind, placebo-controlled Phase 3 study in men with HRR-deficient mCSPC.
Pfizer completes acquisition of Biohaven Pharmaceutical » 13:0210/0310/03/22
Pfizer (PFE) announced…
Pfizer (PFE) announced the completion of its acquisition of Biohaven Pharmaceutical Holding Company Ltd. (BHVN), the maker of NURTEC ODT, a migraine therapy approved for both acute treatment and prevention of episodic migraine in adults. "We are proud to build on Pfizer's legacy of delivering breakthrough medicines for patients living with complex pain disorders," said Aamir Malik, Executive Vice President, Chief Business Innovation Officer, Pfizer. Pfizer acquired all of the outstanding shares of Biohaven not already owned by Pfizer for $148.50 per share in cash, for a total transaction consideration of approximately $11.6B. As a result of the acquisition, Biohaven became a wholly-owned subsidiary of Pfizer. Effective immediately prior to the closing of the acquisition, Biohaven completed the spin-off of Biohaven Ltd., distributing Biohaven Ltd.'s shares to Biohaven's shareholders. Biohaven Ltd., a new company that retained Biohaven's non-CGRP development stage pipeline compounds, holds the Kv7 ion channel activators, glutamate modulation, and myostatin inhibition platforms, preclinical product candidates, and certain corporate infrastructure assets excluded from the Pfizer acquisition. Pfizer, a Biohaven shareholder, received a pro rata portion of Biohaven Ltd.'s shares in the distribution and owns approximately 3% of Biohaven Ltd. Biohaven Ltd. will continue to trade on the New York Stock Exchange under the ticker "BHVN".
Palantir, Concordance announce partnership » 07:0010/0310/03/22
Palantir Technologies and…
Palantir Technologies and Concordance Healthcare Solutions announced a partnership to power the first, fully integrated medical supply chain ecosystem - bringing together inventory and supply chain data from manufacturers, suppliers, distributors, and providers into one cohesive, real-time system.
Fly Intel: Top five weekend stock stories » 20:0410/0210/02/22
TSLA, MRNA, BNTX, PFE, OWL, CHPT, LAZR, RKLB, VCSA, SEAT, PARA, OLPX, DPSGY
Catch up on the…
Catch up on the weekend's top five stories with this list compiled by The Fly: 1. Tesla (TSLA) reported Q3 deliveries of 343,830, with 3% subject to operating lease accounting, and production of 365,923 vehicles. Tesla delivered 18,672 Model S/X and 325,158 Model 3/Y. The company said that, "Historically, our delivery volumes have skewed towards the end of each quarter due to regional batch building of cars. As our production volumes continue to grow, it is becoming increasingly challenging to secure vehicle transportation capacity and at a reasonable cost during these peak logistics weeks. In Q3, we began transitioning to a more even regional mix of vehicle builds each week, which led to an increase in cars in transit at the end of the quarter. These cars have been ordered and will be delivered to customers upon arrival at their destination." 2. Moderna (MRNA) has refused to hand over to China the core intellectual property behind the development of its breakthrough COVID-19 vaccine, leading to a collapse in negotiations on its sale there, Financial Times; Sun Yu, Eleanor Olcott and Donato Paolo Mancini report, citing people familiar with the matter. The company turned down Beijing's request to hand over the recipe for its messenger RNA vaccine because of commercial and safety concerns, said two people involved in negotiations that took place between 2020 and 2021. The vaccine maker says it is still "eager" to sell the product to China, the authors wrote. The mRNA vaccine technology used by Moderna and BioNTech (BTNX)/Pfizer (PFE) provides longer-lasting and higher levels of protection than the inactivated vaccine technology used by Chinese makers. Several Chinese pharma companies are racing to develop a homemade mRNA alternative but have struggled with the emergence of more infectious variants, the publication adds. 3. One year ago, investors couldn't get enough of special-purpose acquisition companies. Now, they can't dump SPACs fast enough, Al Root writes in this week's edition of Barron's. New technologies, new capital, and optimistic business projections had investors dreaming of big gains from these blank-check companies, like the 250% pop in 2020. Now that bubble has popped, the author notes. Many of the stocks got what they deserved after offering financial guidance that has proven wildly off the mark, but not every company has failed so spectacularly, the publication adds. Many look like solid companies that made the bad choice of coming to market via a SPAC, the author writes, such as Blue Owl Capital (OWL), ChargePoint (CHPT), Luminar (LAZR), Rocket Lab (RKLB), Vacasa (VCSA), and Vivid Seats (SEAT). 4. Paramount's (PARA) horror movie "Smile" on the weekend at the North America box office with a $22M debut from 3,645 locations. The film tells the story of a therapist who meets a graduate student who recently witnesses a gruesome suicide. Jessie T. Usher Kyle Gallner, Robin Weigert and Kal Penn co-star. 5. Olaplex Holdings (OLPX) and Deutsche Post DHL Group (DPSGY) saw positive mentions in this week's edition of Barron's.
Moderna refuses China request to reveal vaccine technology, FT reports » 13:5310/0210/02/22
MRNA, PFE, BNTX
Moderna (MRNA) has…
Moderna (MRNA) has refused to hand over to China the core intellectual property behind the development of its breakthrough COVID-19 vaccine, leading to a collapse in negotiations on its sale there, Financial Times; Sun Yu, Eleanor Olcott and Donato Paolo Mancini report, citing people familiar with the matter. The company turned down Beijing's request to hand over the recipe for its messenger RNA vaccine because of commercial and safety concerns, said two people involved in negotiations that took place between 2020 and 2021. The vaccine maker says it is still "eager" to sell the product to China, the authors wrote. The mRNA vaccine technology used by Moderna and BioNTech (BNTX)/Pfizer (PFE) provides longer-lasting and higher levels of protection than the inactivated vaccine technology used by Chinese makers. Several Chinese pharma companies are racing to develop a homemade mRNA alternative but have struggled with the emergence of more infectious variants, the publication adds. Reference Link
What You Missed On Wall Street On Friday » 16:2909/3009/30/22
NKE, MU, RCII, PHG, BCS, VOYA, CRL, CENX, CYBR, TWTR, EADSY, BA, SAVE, JBLU, AAL, TSLA, JOBY, IONQ, PLTR, CFLT, ICPT, PTON, LULU, CCL, CMTL, CIR, UXIN, GFAI
Get caught up quickly on…
Avalara says ISS recommends vote for pending Vista Equity deal » 14:5509/3009/30/22
Avalara, announced that…
Avalara, announced that proxy advisory firm Institutional Shareholder Services has recommended shareholders vote for the company's pending transaction with Vista Equity Partners at its special meeting scheduled for October 14. In its report, ISS noted, "..the proposed transaction provides certainty of value, at a premium to the unaffected price, compared to the significant downside risk of non-approval and the uncertainty surrounding a potential market recovery," according to Avalara.