Here's a roundup of top developments in the biotech space over the last 24 hours.
Scaling the Peaks
(Stocks hitting 52-week highs on June 26)
- AngioDynamics, Inc. (NASDAQ: ANGO)
- Chembio Diagnostics Inc (NASDAQ: CEMI)
- Regenxbio Inc (NASDAQ: RGNX)
- Repligen Corporation (NASDAQ: RGEN)
Down In The Dumps
(Stocks hitting 52-week lows on June 26)
- Achaogen Inc (NASDAQ: AKAO)(FDA approved its antibiotic for one indication and issued complete response letter for another indication)
- Cellectar Biosciences Inc (NASDAQ: CLRB)
- Cytori Therapeutics Inc (NASDAQ: CYTX)(record date for rights offering)
- Erytech Pharma SA (ADR) (NASDAQ: ERYP)
- Merrimack Pharmaceuticals Inc (NASDAQ: MACK)
- Oncolytics Biotech, Inc. (USA) (NASDAQ: ONCY)
- Soligenix, Inc. Common Stock (NASDAQ: SNGX)
Stocks In Focus FDA Panel Rules Against Pain Therapeutics' Pain Drug
Pain Therapeutics, Inc. (NASDAQ: PTIE) announced that FDA's Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee, which met to discuss its NDA for remoxy, oxycodone extended-release capsules, voted 14 to 3 against the approval of it for the management of pain, severe enough to require around-the-clock, long-term opioid treatment, and for which alternative treatment options are inadequate.
Remoxy is the company's lead product candidate, and is an abuse deterrent extended-release oral formulation of oxycodone, a widely prescribed opioid medication. It has been licensed from DURECT Corporation (NASDAQ: DRRX).
The PDUFA data for the completion of the FDA review has been set for Aug. 7
Pain Therapeutics shares plummeted 70.11 percent to $2.55, while DURECT fell 11.49 percent to $1.54.
Amicus Says European Regulators Sought Further Clinical Data For Pompe Disease Drug
Amicus Therapeutics, Inc. (NASDAQ: FOLD) announced the Scientific Advice Working Party, or SAWP, within the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, which evaluated its development program for AT-GAA for Pompe disease, determined that the efficacy data to-date appear promising but the current clinical package is not sufficient for a Conditional Marketing Authorization Approval at this time,
The company said it will continue to engage with the agency in 2019 concerning a potential pathway for conditional approval, with further data on both efficacy and safety.
The stock slumped 9.62 percent to $14 in after-hours trading.
On The Radar
Neon Therapeutics, a developer of immunotherapy platform for targeting various types of cancers, priced its 6.25-million share offering at $16. The shares are expected to trade on the Nasdaq on June 27 under the ticker symbol (NASDAQ: NTGN).
See more from Benzinga
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