Biotech stocks continued to be under pressure in the past week amid broader market weakness, precipitated by economic worries. Company-specific developments also triggered downward moves.
Here's a compilation of five stocks that should be on your radar in the week of June 13:
Novavax, Inc. NVAX stock retreated last week after there was no word on the authorization of its COVID-19 vaccine in the U.S. An advisory committee of the Food and Drug Administration that met last Tuesday unanimously recommended the approval of the vaccine. The FDA has yet to give the final verdict.
Rival vaccines from Moderna, Inc. MRNA, Pfizer, Inc. PFE-BioNTech SE BNTX and Johnson & Johnson JNJ had all secured authorization within a day or two of the Adcom meetings.
Reports suggest the delay is due to the time the FDA requires to review a change in the manufacturing process, which Novavax communicated a few days before the Adcom meeting.
Novavax shares, which rallied to an intraday high of $52.95 on Wednesday in reaction to the positive Adcom verdict, pulled back notably before ending Friday's session at $40.62, according to Benzinga Pro.
A positive decision could help Novaxax bounce back during the week.
2. Acadia Pharma
Acadia Pharmaceuticals Inc. ACAD has a catalyst in the form of an Adcom meeting on Friday.
The FDA's Psychopharmacologic Drugs Advisory Committee will discuss Acadia's supplemental new drug application for Nuplazid tablets for the proposed treatment of hallucinations and delusions associated with Alzheimer's disease psychosis.
An application seeking approval of Nuplazid as a treatment option for dementia-related psychosis was rejected by the FDA in April 2021.
SVB Leerink analyst Marc Goodman is less hopeful of a positive verdict.
"We remain skeptical that the FDA will change its mind on its consistent recommendation to run another study in ADP to provide the strongest evidence for efficacy in this indication," the analyst said.
There is still a small chance and a probability of success of 35% in SVB Leerink's model, he added.
3. Rhythm Pharma
Rhythm Pharmaceuticals, Inc. RYTM has an FDA decision date of June 16 for Imcivree (setmelanotide) as a treatment option for Bardet-Biedl syndrome or Alström syndrome.
The drug has already been approved for treating chronic weight management in adult and pediatric patients 6 years of age and older, with obesity, due to the deficiency of POMC, PCSK1, or LEPR – proteins that affect the pathway responsible for transmitting signals about when to eat and when to stop eating.
The original PDUFA date of March 16 was extended by three months, as the FDA needed additional time to review clinical efficacy data submitted by the company upon the agency's request to conduct additional subgroup analyses.
Potential approval and the commercial launch of Imcivree for the expanded indication will be a major value driver for Rhythm Pharma shares in 2022, according to Needham analyst Joseph Stringer.
4. Satsuma Pharma
Satsuma Pharmaceuticals, Inc. STSA is scheduled to host a key opinion leader webinar on June 16, at 10:30 am ET. The company is scheduled to discuss its STS101, dihydrogotamine nasal powder, which is being evaluated as a treatment option for acute migraine.
5. Okyo Pharma
U.K.-based OKYO Pharma Limited OKYO, a company focused on discovering and developing inflammatory eye disease and ocular pain treatments, listed its shares on the Nasdaq May 17. This followed an initial public offering of 625,000 ADS at a price of $4 apiece.
Okyo has two pipeline assets, namely OK-101, which is being evaluated for dry eye disease, uveitis and allergic conjunctivitis, and OK-201, which is in the discovery stage. The company expects to submit an investigational new drug application for the former to the FDA in the third quarter and start the Phase 2 study in the fourth quarter.
The ADSs of the company closed the debut session at $3.62, a discount to the IPO price, and has pulled back further.
With the 25-day IPO quiet period expiring this week, analysts will begin coverage of the stock. This should potentially be a stock mover.
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