These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:
Pipeline and key clinical candidates for these companies:
Opiant Pharmaceuticals is building a franchise of new medicines to combat addictions and drug overdose. OPNT003, nasal nalmefene, is a high-affinity mu-opioid receptor antagonist that reduces the binding of opioids to this receptor, limiting respiratory depression, the primary cause of overdose injury and death. Opiant has initiated a rolling submission of a New Drug Application to the FDA for OPNT003, using the 505(b)(2) pathway and intends to complete the filing in the fourth quarter of 2022. OPNT003 was granted Fast Track Designation in November 2021.
MorphoSys is focused on discovering, developing, and delivering innovative cancer medicines. Tafasitamab is a humanized Fc-modified CD19 targeting immunotherapy. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor (XNCR).
Stoke Therapeutics is dedicated to addressing the underlying cause of severe diseases by upregulating protein expression with RNA-based medicines. Stoke is developing antisense oligonucleotides, or ASOs, to selectively restore protein levels. Stoke’s first compound, STK-001, is in clinical testing for the treatment of Dravet syndrome, a severe and progressive genetic epilepsy. Stoke is pursuing the development of STK-002 for the treatment of autosomal dominant optic atrophy, or ADOA, the most common inherited optic nerve disorder.
Satsuma Pharmaceuticals is developing a novel therapeutic product, STS101, for the acute treatment of migraine. STS101 is a unique and proprietary nasal powder formulation of the well-established anti-migraine drug, dihydroergotamine mesylate, or DHE, administered via Satsuma’s proprietary nasal delivery device.
PDS Biotech is a clinical-stage immunotherapy company developing a pipeline of targeted cancer and infectious disease immunotherapies based on its proprietary Versamune and Infectimune T cell-activating technology platforms. To date, its lead Versamune clinical candidate, PDS0101, has demonstrated the potential to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV-positive cancers in multiple Phase 2 clinical trials.
Recent news on these stocks:
JonesTrading analyst Sean Kim downgraded Satsuma Pharmaceuticals to Hold from Buy and removed his prior price target following the failure of the STS101 SUMMIT Phase 3 efficacy trial in acute treatment of migraine. He seeks better clarity on the path forward and plans for STS101 following the "disappointing" trial results, Kim said.
Mizuho analyst Vamil Divan downgraded Satsuma Pharmaceuticals to Neutral from Buy with a price target of $2, down from $13, following the failure of the SUMMIT trial in migraine. The analyst believes the potential for STS101 "diminishes substantially without efficacy data in the label." In addition, the fate of STS101 is uncertain, as the filing of STS101 through a 505(b)(2) bioequivalence pathway likely and appropriately depends on the completion of an alternative option, Divan told investors.
Opiant Pharmaceuticals announced that it has entered into a definitive merger agreement to be acquired by Indivior, a subsidiary of Indivior (INVVY). Under the terms of the agreement, Indivior will acquire all of the outstanding shares of Opiant for upfront consideration of $20.00 per share in cash at closing, plus contingent value rights, or CVRs, representing, if achieved, potential additional payments over a period of seven years of up to $8.00 per share. Achievement of the CVR payments, if any, are based on attaining certain revenue thresholds for OPNT003, nasal nalmefene, Opiant's investigational treatment for opioid overdose, as detailed below. The upfront payment at closing of $20.00 per share represents a premium of approximately 111% to Opiant's closing share price on November 11, and 99% premium to the 30-day volume-weighted average share price. Inclusive of each of the CVR payments, the total potential transaction value represents a premium of up to 195% and 178%, respectively. The transaction has been unanimously approved by the boards of directors of each company.
Roche (RHHBY) announced results from the GRADUATE I and II studies evaluating gantenerumab in people with mild cognitive impairment due to Alzheimer's and mild Alzheimer's dementia, collectively called early Alzheimer's disease. The studies did not meet their primary endpoint of slowing clinical decline. Gantenerumab was well tolerated, including the subcutaneous administration. Study participants treated with gantenerumab showed a slowing of clinical decline in GRADUATE I and GRADUATE II of -0.31 and -0.19, respectively, from baseline score on the Clinical Dementia Rating-Sum of Boxes, however, neither was statistically significant. This represents a relative reduction in clinical decline of 8% in GRADUATE I and 6% in GRADUATE II compared with placebo. The level of beta-amyloid removal, the protein that builds up to make plaques in the brains of people with Alzheimer's disease, was lower than expected, Roche added. Roche was partnering with MorphoSys on the GRADUATE I and II studies.
Stoke Therapeutics reported a Q3 loss of (66c) against consensus estimates of (68c), and reported Q3 revenue $2.91M against a consensus of $2.45M. "We are encouraged by the data from our ongoing studies of STK-001, which continue to demonstrate favorable safety findings and reductions in seizure frequency among a highly refractory group of patients," said Barry Ticho, chief medical officer of Stoke Therapeutics. "Half of the patients in these studies were taking four or more anti-seizure medicines, including fenfluramine, setting a high bar for STK-001 to demonstrate additional benefit. Even so, 74% of patients experienced a reduction in seizure frequency following three doses of STK-001. Most notable is the 55% median reduction observed among the small group of patients treated with three doses of 45mg. Based on these data, we believe we have entered the therapeutic range, which is translating to a clinical benefit for patients. We look forward to additional data in 2023."
Satsuma Pharmaceuticals reported topline results from the STS101 SUMMIT Phase 3 efficacy trial. Although topline data showed numerical differences in favor of STS101 5.2 mg versus placebo on the pre-specified co-primary endpoints of freedom from pain and freedom from most bothersome symptom at two hours post-administration, these differences did not achieve statistical significance. STS101 did, however, demonstrate significant effects on both freedom-from-pain and MBS-free endpoints by three hours post-dose and at all subsequent timepoints at which efficacy was assessed. In addition, STS101 was statistically superior to placebo on multiple key secondary endpoints considered clinically relevant and recommended for assessment in acute-treatment-of-migraine efficacy trials by the U.S. Food and Drug Administration in its current industry guidance document and/or the International Headache Society's guidelines for controlled trials. Consistent with clinical trial experience to date, STS101 demonstrated a favorable safety and tolerability profile in SUMMIT.
PDS Biotechnology reported a Q3 loss of (26c) against a consensus of (28c). PDS Biotech's cash balance as of September 30, 2022 was approximately $71.6 M. "Q3 has been monumental for PDS Biotech, and we continue to make strides towards commercialization of our lead candidate, PDS0101," stated CEO Frank Bedu-Addo. "We've remained focused on progressing our four Phase 2 clinical programs, most recently, announcing data from our IMMUNOCERV trial in locally, advanced cervical cancer. 100% of patients had a clinical response with tumor shrinkage of over 60% at the midpoint evaluation, and 89% of patients had a complete response with no evidence of disease at day 170, when treated with a combination of PDS0101 and chemotherapy...And, with VERSATILE-002 in which PDS0101 is combined with KEYTRUDA, we are preparing for a registrational trial after our successful end-of-Phase 2 meeting with the FDA. To date, we have presented PDS0101 Phase 2 efficacy data in over 60 patients and safety data in over 100 patients." CFO Matthew Hill stated, "...This August, we increased our cash position by entering into a loan agreement with Horizon Technology Finance Corporation, where we received an initial tranche of $25M in term loans. This financing provides PDS Biotech with the financial resources and runway needed to prepare for a registrational trial for our lead candidate, PDS0101, and to advance our preclinical pipeline."
About “Biotech Alert”
The Fly will report on a selection of biotech stocks seeing a surge in interest from retail and financial professional investors, based on data from InvestingChannel.
This Fly exclusive recap reveals the biotech stocks that are seeing a spike in searches among the 15-plus million retail and financial professional investors through InvestingChannel's online financial news media ecosystem.
This increased attention from the investors may be in response to, or advance of, outsized moves for stocks in the biotech sector, which tend to be volatile and prone to sharp swings in share price around binary events such as clinical study results and FDA approvals.