These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:
- Acer Therapeutics (ACER), 508% surge in interest
- Sarepta Therapeutics (SRPT), 95% surge in interest
- Cymabay Therapeutics (CBAY), 84% surge in interest
- Corbus Pharmaceuticals (CRBP), 70% surge in interest
Pipeline and key clinical candidates for these companies:
Acer Therapeutics is focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. In the U.S., OLPRUVA is approved for the treatment of urea cycle disorders involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase, or argininosuccinic acid synthetase. Acer is also advancing a pipeline of investigational product candidates for rare and life-threatening diseases, including: OLPRUVA for treatment of various disorders, including Maple Syrup Urine Disease; ACER-801 for treatment of Vasomotor Symptoms, post-traumatic stress disorder and prostate cancer; and EDSIVO for treatment of vascular Ehlers-Danlos syndrome in patients with a confirmed type III collagen mutation.
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.
CymaBay Therapeutics is focused on liver and other chronic diseases that have high unmet medical need. The company has received breakthrough therapy designation from the FDA, PRIority MEdicines status from the European Medicines Agency and orphan drug status in the U.S. and Europe for seladelpar, a first-in-class treatment for people with primary biliary cholangitis, or PBC.
Corbus Pharmaceuticals is an oncology company "committed to connecting innovation to our purpose of improving lives by developing new medicines that target the nexus between the immune system and cancer." Corbus’ current pipeline includes anti-integrin monoclonal antibodies that block activation of TGFβ and small molecules that activate or inhibit the endocannabinoid system.
Recent news on these stocks:
March 17
Acer Therapeutics announced that topline results from its Phase 2a proof of concept clinical trial to evaluate ACER-801 as a potential treatment for moderate to severe Vasomotor Symptoms, VMS, associated with menopause showed that ACER-801 was safe and well-tolerated but did not achieve statistical significance when evaluating ACER-801’s ability to decrease the frequency or severity of hot flashes in postmenopausal women. As a result, Acer is pausing the ACER-801 program until Acer has conducted a thorough review of the full data set. Concurrently, Acer is continuing to focus on preparation for its commercial launch of OLPRUVA for oral suspension for the treatment of urea cycle disorders and the ongoing pivotal Phase 3 clinical evaluation of EDSIVO for vascular Ehlers-Danlos Syndrome in patients with a confirmed type III collagen mutation, subject in each instance to availability of additional capital beyond early in Q2 2023.
H.C. Wainwright analyst Ed Arce raised the firm’s price target on CymaBay to $12 from $10 and kept a Buy rating on the shares. On the company’s earnings call, management focused on the breadth of clinical and real-world data on seladelpar in the treatment of primary biliary cholangitis, the analyst told investors in a research note. The firm continues to have "high confidence" in seladelpar, especially based on ENHANCE data.
March 16
Sarepta Therapeutics announced that at its late cycle meeting for the SRP-9001 biologics license application, the FDA’s Office of Therapeutics has determined that an advisory committee meeting will be held for SRP-9001 in advance of the May 29, 2023 regulatory action date. SRP-9001 is Sarepta’s investigational gene therapy for the treatment of Duchenne muscular dystrophy. "FDA’s decision to hold a public advisory committee meeting on the SRP 9001 BLA is a change from the communicated position at the midcycle meeting. FDA leadership has noted publicly that FDA is interested in exploring the use of surrogate endpoints, biomarkers, and innovative approaches like accelerated approval to advance cell and gene therapies, particularly for rare, life-ending degenerative diseases. It is our understanding that as one of the first gene therapy BLAs founded on a surrogate endpoint, the advisory committee will primarily relate to the totality of evidence supporting the conclusion that the SRP 9001 dystrophin is reasonably likely to predict clinical benefit, the standard for accelerated approval," said Doug Ingram, CEO of Sarepta. "While we are disappointed that we must communicate a change in decision after our prior statement on the topic, we are not disappointed with the decision to hold an advisory committee. We had been preparing for an advisory committee meeting from the filing of the BLA in the fall of 2022. We will be well prepared, and look forward to presenting the wealth of evidence supporting the transformative potential of SRP-9001. We would like to thank CBER for moving expeditiously to schedule the advisory committee in advance of our May 29, 2023, regulatory action date, once the change in decision was made."
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.
Published first on TheFly
See today’s best-performing stocks on TipRanks >>
Read More on CRBP:
