The Daily Biotech Pulse: FDA Nod For Osmotica, OptiNose Strikes Co-promotion Deal, Orphan Drug Designation For AnaptysBio

Here's a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs July 8)

• Akero Therapeutics Inc AKRO
• Altimmune Inc ALT
• Amicus Therapeutics, Inc. FOLD
• AMRYT PHARMA PL/S ADR AMYT (reacted to its ADSs commencing trading on the Nasdaq)
• argenx SE – ADR ARGX
• Assembly Biosciences Inc ASMB
• Biohaven Pharmaceutical Holding Co Ltd BHVN
• Biondvax Pharmaceuticals Ltd – ADR BVXV
• Crispr Therapeutics AG CRSP
• Cytokinetics, Inc. CYTK
• Eli Lilly And Co LLY
• Emergent Biosolutions Inc EBS
• GENMAB A/S/S ADR GMAB
• GenMark Diagnostics, Inc GNMK (pre-announced above-consensus Q2 revenue)
• Immunomedics, Inc. IMMU
• Intellia Therapeutics Inc NTLA
• MacroGenics Inc MGNX
• Mersana Therapeutics Inc MRSN
• Nantkwest Inc NK
• NeoGenomics, Inc. NEO
• Opko Health Inc. OPK
• Pacira Biosciences Inc PCRX
• Quidel Corporation QDEL
• Seres Therapeutics Inc MCRB
• Syros Pharmaceuticals Inc SYRS
• TG Therapeutics Inc common stock TGTX (announced publication of pre-clinical data on its umbralisib)
• Twist Bioscience Corp TWST - announced a partnership with Takeda Pharmaceutical Co Ltd TAK for expanding biologics discovery
• VBI Vaccines Inc VBIV
• Zai Lab Ltd ZLAB

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows July 8)

• Brickell Biotech Inc BBI
• Intercept Pharmaceuticals Inc ICPT
• ORIC Pharmaceuticals Inc ORIC
• Polypid Ltd PYPD
• VIVUS, Inc. VVUS (announced Chapter 11 filing and plan for being taken over by its creditor

Stocks In Focus

Biogen Announces Publication Of Positive Phase 1/2 Data For Neurodegenerative Disease Drug

Biogen Inc BIIB announced publication in the New England Journal of Medicine positive results from a Phase 1/2 study of tofersen for the potential treatment of superoxide dismutase 1, or SOD 1, amyotrophic lateral sclerosis, or ALS. A mutation in the SOD1 gene is believed to be a genetic driver of disease in approximately 2% of all ALS cases, the company said.

OptiNose Announces Co-Promotion Agreement For Nasal Spray In US

OptiNose Inc OPTN announced an agreement with kaléo, a pharmaceutical company, to co-promote Xhance exhalation nasal spray 93 mcg for the treatment of nasal polyps in patients 18 and older in the U.S.

Under the terms of the agreement, kaléo will promote Xhance to an agreed-upon audience of office-based health care professionals, rapidly increasing promotional reach and frequency.

The stock was up 16.71% at $4.96 premarket Thursday.

Anaptys Bio's Rare Psoriasis Drug Gets Orphan Drug Designation

AnaptysBio Inc ANAB said the FDA has granted orphan drug designation for imsidolimab, its proprietary anti-interleukin-36 receptor antibody, for the treatment of patients with generalized pustular psoriasis.

The company said it expects to release additional data and regulatory strategy update from the Phase 2 GALLOP trial that is evaluating imsidolimab in the second half of 2020.

The company plans to expand clinical development of the investigational compound to additional indications in the second half of 2020. It also said it expects to release top-line data from the Phase 2 POPLAR trial in palmoplantar pustulosis in the second half of 2020.

The stock rose 14.15% to $25.98 in after-hours trading.

See also: The Week Ahead In Biotech: Endo, Eagle Pharma FDA Decisions, ObsEva Late-Stage Readouts In Focus

Applied DNA Creates COVID-19 Testing Subsidiary, Receives Approval For EUA Amendment

Applied DNA Sciences Inc APDN announced the formation of a wholly owned subsidiary, Applied DNA Clinical Labs, LLC, dedicated to the commercial development of its tests in virology, for the detection of COVID-19, and in oncology, for the detection and enumeration of invasive circulating tumor cells.

The company also said the amendment of its EUA for its molecular test for SARS-CoV-2 was approved by FDA to include extraction and concentration of the viral RNA by a magnetic method of nucleic acid extraction that lends itself easily to high throughput scaling with robotics and diversifies the two extraction methods already covered by the existing EUA.

The stock was advancing 16.21% to $9.32 premarket Thursday.

Acer Announces Positive Data For Taste-Masked Immediate Release Formulation Of Urea Cycle Disorder Drug

Acer Therapeutics Inc ACER announced data from a food effect study in healthy volunteers showing that administration of ACER-001, its taste-masked, immediate release formulation of sodium phenylbutyrate, may offer improved disease management in patients with urea cycle disorders compared to treatments requiring administration with food.

The company said it expects to submit the ACER-001 NDA in the first half of 2021, assuming successful completion of additional nonclinical work and long-term stability data, and subject to additional capital.

The stock was up 19.88% at $3.86 premarket Thursday.

FDA Accepts AstraZeneca's Application For Brilinta Label Expansion With Priority Review

AstraZeneca plc AZN said the FDA has accepted a supplemental New Drug Application and granted Priority Review for Brilinta for the reduction of subsequent stroke in patients who experienced an acute ischemic stroke or transient ischemic attack.

The stock was adding 0.3% to $54.35 premarket Thursday.

Osmotica Announces FDA Approval For Drug To Treat Droopy Eyelid

Osmotica Pharmaceuticals PLC OSMT said the FDA has approved Upneeq, its novel treatment for acquired blepharoptosis, or ptosis, a condition characterized by the abnormal drooping of the upper eyelid that can limit field of vision.

In premarket trading Thursday, the stock was jumping 5.35% to $6.70.

Shockwave Medical Gets Mixed Ruling In Patent Appeal Case

The Patent Trial and Appeal Board ruled that a key claim is valid in the inter partes review initiated against Shockwave Medical Inc SWAV by Cardiovascular Systems Inc CSII. 

"We are very pleased that the court validated claim 5 of our ‘371 patent, which protects the broad embodiment of our IVL technologies," said Doug Godshall, CEO of Shockwave.

The PTAB ruled that some claims of a second patent are valid and that all claims of a third patent are invalid.

Shockwave shares were down 0.81% at $46.60 premarket Thursday.

Altimmune Teams With DynPort On COVID-19 Vaccine Funding

Altimmune said it has entered into a teaming agreement with DynPort Vaccine Company, a General Dynamics Information Technology company, to coordinate U.S. government funding efforts and, if successful, to provide program management, drug development activity integration and regulatory support for AdCOVID, its single-dose intranasal COVID-19 vaccine candidate.

Offerings

Otonomy Inc OTIC said it has commenced an underwritten public offering of its common stock. All shares of common stock to be sold in the offering will be offered by the company. In lieu of common stock, the company plans to offer to certain investors pre-funded warrants to purchase shares of its common stock in an underwritten public offering.

The stock was sliding 5.34% to $3.37 premarket.

Revolution Medicines Inc RVMD priced its underwritten public offering of 6 million shares of common stock at $26 per share, for raising gross proceeds of $156 million. All of the shares are being offered by the company. The company expects the offering to close July 13.

The stock was seen receding 1.85% to $27.50 premarket Thursday.

NanoViricides Inc NNVC announced the commencement of an underwritten public offering. The company said it intends to use the net proceeds from the offering to fund general corporate purposes, including its drug development programs for COVID-19 and for shingles.

The stock fell 8.04% to $8.01 premarket Thursday.

Qualigen Therapeutics Inc QLGN said it has entered into a definitive agreement with a single institutional investor for the purchase and sale for $8 million in stock: 1.2 million common shares, 780,198 pre-funded warrants and 1.98 million common warrants at a combined purchase price of $4.165 in a registered direct offering priced at-the-market.

Qualigen shares were trading 1.95% higher to $4.19 premarket Thursday.

Related Link: Attention Biotech Investors: Mark Your Calendar For These July PDUFA Dates