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:
Heron Therapeutics is a commercial-stage biotechnology company that says its "advanced science, patented technologies, and innovative approach to drug discovery and development have allowed it to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients."
Cidara is developing long-acting therapeutics designed to help improve the standard of care for patients facing serious diseases. The company's portfolio is comprised of new approaches aimed at transforming existing treatment and prevention paradigms, first with its lead Phase 3 antifungal candidate, rezafungin, in addition to DFCs targeting viral and oncology diseases from Cidara's proprietary Cloudbreak platform.
Sarepta Therapeutics engineers precision genetic medicine for rare diseases. The company holds leadership positions in Duchenne muscular dystrophy, or DMD, and limb-girdle muscular dystrophies, or LGMDs, and currently has more than 40 programs in various stages of development. Sarepta's pipeline is driven by its multi-platform Precision Genetic Medicine Engine in gene therapy, RNA and gene editing.
Recent news on these stocks:
Though the ultimate benefit/risk vote on SRP-9001 at the FDA panel meeting was split 8-6 in favor yes, two yes voters not convinced on SRP-9001 microdystrophin as a surrogate, Citi tells investors in a research note. However, given precedents for FDA action post split votes and supportive commentary from Director Peter Marks, FDA approval by the by the May 29 action date is "highly likely," the analyst tells investors. The firm increased its probability of success to 95% from 75%. However, Citi expects the shares to only partially price in approval between now and the FDA action date, saying debate on accelerated approval likely remains given the split vote and given the EMBARK Phase 3 overhang. Sarepta could see $40 of upside today to the $160s per share, the analyst adds.
JPMorgan says a "close win is still a win" after an FDA panel voted 8-6 in favor of Sarepta Therapeutics' SRP-9001. The positively skewed vote helps de-risk the ultimate accelerated approval of SRP-9001, an experimental gene therapy for Duchenne muscular dystrophy, the analyst tells investors in a research note. The firm sees the shares having the potential to "grind to" the $150-$175 with time and go higher on a potential approval. Friday's vote is a "big win" for Sarepta, says JPMorgan. The firm reiterates an Overweight rating on the shares with a $206 price target. The stock halted Friday morning into the FDA panel meeting at $120.20.
Sarepta Therapeutics announced that the Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee voted 8 to 6 in support of accelerated approval of SRP-9001 for the treatment of ambulatory patients with Duchenne muscular dystrophy with a confirmed mutation in the DMD gene. SRP-9001 is intended to treat the underlying cause of Duchenne, which is characterized by mutations in the dystrophin gene that results in the lack of dystrophin protein. In the absence of dystrophin, which is required to strengthen and protect muscles, muscles become weakened and damaged, the company said in a statement. "The committee's positive vote is based on the evaluation of the totality of evidence including the SRP-9001 product design as well as biological and empirical data," it added. The Biologics License Application for SRP-9001 is currently under priority review by the FDA with a regulatory action date of May 29. "With the May 29 action date our top priority, we will work collaboratively with the FDA to complete the review of our BLA for SRP 9001," said Doug Ingram, CEO of Sarepta.
Heron Therapeutics reported Q1 EPS of (27c) against a consensus of (20c), reported Q1 revenue of $29.6M against a consensus of $29.69M. "We continued to make steady progress in the first quarter of 2023 at Heron, highlighted by the approval and launch of our fourth commercial product, APONVIE. We are pleased with the steady growth in the oncology care franchise and remain encouraged by the market potential for ZYNRELEF and APONVIE," said Craig Collard, new CEO. "Looking ahead, we are focused on reducing our cash burn and advancing a streamlined organization that we believe will begin to show significant growth while also continuing to improve patient's lives."
Cidara Therapeutics reported Q1 EPS of 3c against a consensus of (4c), reported Q1 revenue of $26.0M against a consensus of $18.68M. "The recently received $20.0M milestone payment from Melinta Therapeutics following the FDA approval of Rezzayo further strengthened our balance sheet," said CEO Jeffrey Stein. "Importantly, we remain eligible to receive additional non-dilutive capital of up to approximately $47.1M in development and regulatory milestones from our existing partnerships contingent on successful completion of activities planned for the next twelve months. We are now highly focused on advancing our Cloudbreak drug-Fc conjugate platform programs as we work to develop a new generation of immunotherapies to treat and prevent serious diseases, including multiple oncologic and autoimmune indications. We expect to file an IND in 2024 for our first oncology DFC candidate, CD421, a potential first-in-class inhibitor of CD73. We are excited to share further insights into these promising ongoing programs at our planned R&D Day in the second half of this year."
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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 20-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.