The Daily Biotech Pulse: FDA Nod For Novartis, Jazz Positive Late-Stage Data For Sleep Disorder Drug, Genfit IPO

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 on March 26)

• Baxter International Inc BAX
• Biohaven Pharmaceutical Holding Co Ltd BHVN
• Eli Lilly And Co LLY
• Merck & Co., Inc. MRK
• Novartis AG NVS
• Qiagen NV QGEN
• CYCLERION THERA/SH CYCNV
• Orchard Therapeutics PLC – ADR ORTX
• PhaseBio Pharmaceuticals Inc PHAS

Down In The Dumps

(Biotech stocks hitting 52-week lows on March 26)

• Achaogen Inc AKAO
• Aerpio Pharmaceuticals Inc ARPO
• Fennec Pharmaceuticals Inc FENC
• OpGen Inc OPGN(priced an underwritten public offering of 9 million shares at 60 cents per share)

Stock In Focus

FDA Greenlights Novartis Multiple Sclerosis Drug

Novartis said the FDA approved its Mayzent, or siponimod for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease, in adults.

The company expects to make Mayzent available in the U.S. in about a week.

Jazz Sleep Disorder Drug Aces Late-Stage Trial

Jazz Pharmaceuticals PLC JAZZ announced positive top-line results from a Phase 3 study evaluating the efficacy and safety of JZP-258 for the treatment of cataplexy and excessive daytime sleepiness in adult patients with narcolepsy.

The company said it will present the data at an upcoming medical meeting. Data from the trial and interim data from an ongoing 24-week open-label, safety study will be included in the planned NDA submission to the FDA, Jazz said.

The stock gained 2.53 percent to $140 in after-hours trading.

Agios' Drug For Blood Cancer Patients With Specific Mutation Gets Breakthrough Therapy Designation

Agios Pharmaceuticals Inc AGIO said the FDA has granted Breakthrough Therapy designation for Tibsovo in combination with azacitidine for the treatment of newly-diagnosed acute myeloid leukemia with an IDH1 mutation in adult patients who are over 75 years, or who have comorbidities that preclude use of intensive induction chemotherapy.

FDA To Respond to Ampio's Resubmitted SPA Regarding a Confirmatory Phase 3 Trial of Osteoarthritis Drug

Ampio Pharmaceuticals Inc AMPE said on March 11, it resubmitted a Special Protocol Assessment, or SPA, with the FDA for a confirmatory Phase 3 trial of its biological drug Ampion for treating patients with osteoarthritis of the knee.

The FDA has agreed to respond to the SPA submission no later than April 25.

"As site recruitment and patient identification for the trial are currently underway, we will provide an update and commence the trial as soon as practicable after the SPA is awarded," the company said.

The stock jumped 16.47 percent to 65.4 cents in after-hours trading.

See Also: Aldeyra's Eye Inflammation Drug Aces Late-Stage Trial, Stock Rises 60%

Eli Lilly In-licenses Novel Preclinical Target for Autoimmune Diseases

Lilly announced a global licensing and research collaboration agreement with ImmuNext for the latter's novel preclinical target that could lead to potential new medicines for autoimmune diseases by regulating immune cell metabolism.

For in-licensing the preclinical immunometabolism target, Lilly agreed to pay ImmuNext an upfront payment of $40 million, and potential development and commercialization milestone payments of up to $565 million, as well as tiered royalties, ranging from the mid-single to low-double digits on product sales.

Additionally, the companies struck a 3-year research collaboration to support the development of the target.

Common Stock Offering

Moleculin Biotech Inc MBRX intends to offer and sell units consisting of shares of its common stock and warrants in an underwritten public offering. All units sold in the offering will be sold by the company.

The company said it intends to use the proceeds to fund its planned clinical trials and preclinical programs, for other R&D activities and for general corporate purposes.

The stock slid 12.50 percent to $1.05 in after-hours trading.

Precision Therapeutics Inc AIPT announced a proposed public offering of its common stock and warrants to purchase common stock. The company intends to use the net proceeds for working capital and general corporate purposes and also to repay indebtedness.

The stock fell 8.60 percent to 73 cents in after-hours trading.

Earnings

PhaseBio reported a loss of 26 cents per share for the fourth quarter of 2018 compared with a loss of $3.14 per share a year ago and the consensus loss estimate of 31 cents per share. The company earned grant revenues of $257,000 for the recent fourth quarter.

The stock fell 6.37 percent to $8.52 in after-hours trading.

Curis, Inc. CRIS reported a fourth-quarter net loss of 18 cents per share, narrower than the year-ago loss of 24 cents per share. Revenues fell year-over-year from $3.3 million to $2.8 million.

Analysts, on average, estimated a loss of 21 cents per share on revenues of $2.6 million.

Oberland Capital financing deal, according to the company, has provided it with the financial flexibility to aggressively pursue its three novel clinical programs.

The stock rallied 4.98 percent to $2.11 in after-hours trading.

On The Radar

Clinical Trial Results

Fibrocell Science Inc FCSC will release updated Phase 1/2 data for FCX-007, its treatment candidate for recessive dystrophic epidermolysis bullosa.

Earnings

• Affimed NV AFMD FY18 EPS €(0.32) vs €(0.69) In FY17, Sales €23.735M
• Eyenovia Inc EYEN Q4 EPS $(0.60) Misses $(0.43) Estimate
• Cyclacel Pharmaceuticals Inc CYCC (after the market close)
• Osmotica Pharmaceuticals PLC OSMT (after the market close)

IPO

Genfit, a biopharma company focusing on developing therapies and diagnostic solutions for metabolic and liver-related diseases, priced its upsized initial public offering of 6.65 million shares at $20.32 per ADS. The ADSs are to be listed on the Nasdaq under the ticker symbol GNFT.