The Daily Biotech Pulse: Novavax Reports Positive Influenza Vaccine Trial Data, Flexion Warns Of Revenue Shortfall, Retrophin's New CEO

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

None of the biotech stocks reached 52-week highs Thursday.

Down In The Dumps

(Biotech Stocks Hitting 52-week lows on Jan. 3)

• Aevi Genomic Medicine Inc GNMX
• Bristol-Myers Squibb Co BMY
• Coherus Biosciences Inc CHRS
• Myokardia Inc MYOK
• Selecta Biosciences Inc SELB
• Tricida Inc TCDA

Stocks In Focus

Novavax Reports Positive Mid-stage Trial Data For Influenza Vaccine

Novavax, Inc. NVAX announced positive top-line results for the Phase 2 trial of NanoFlu, its influenza vaccine candidate. The company said the mid-stage trial confirmed the Phase 1/2 results, demonstrating improved immune responses over Fluzone.

The trial assessed safety and immune responses of several quadrivalent formulations of NanoFlu, with or without the company's Matrix-M adjuvant, relative to two U.S.-licensed influenza vaccines.

Novavax said it will again meet with the FDA in H'19 to discuss the Phase 2 data, the trial design of the Phase 3 study, and the use of accelerated approval. The late-stage study is planned to be started in 2019.

The stock rallied 10.29 percent to $2.25 in after-hours trading.

Verastem to Focus On Investigation of Duvelisib In Other Tumor Types In 2019

Delving on recent progress and outlining its strategic priorities, Verastem Inc VSTM said it's entering 2019 with a strong balance sheet to achieve corporate objectives. The company noted that the FDA approved Copiktra (duvelisib) in September for treating adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic leukemia after at least two prior therapies. The product also received accelerated approval for follicular lymphoma.

Verastem said its focus in 2019 will be on continued investigation of duvelisib in additional tumor types, including peripheral T-cell lymphoma, both as a monotherapy and in combination with other anti-cancer agents.

The stock advanced 4.84 percent to $3.68 in after-hours trading.

Flexion Expects Below-consensus Revenues For Q4

Flexion Therapeutics Inc FLXN announced preliminary Q4 results, expecting revenues of $9.5 million, up 36 percent quarter-over-quarter. Revenues for 2018 are expected to be $22.5 million. The revenue guidance for the quarter and the year were below consensus.

For 2019, the company expects product revenues of $65 million to $80 million.

The stock fell 5.27 percent to $11.68 in after-hours trading.

SCYNEXIS Targets NDA Filing For its Anti-fungal Agent In 2020

Updating the progress on its pipeline, SCYNEXIS Inc SCYX said it's focused on timely completion of its VANISH Phase 3 trials that is evaluating its investigational anti-fungal agent ibrexafungerp for vulvovaginal candidiasis.

The company expects an NDA filing in the second half of 2020.

Also, the company said it has started 2019 with $51 million in cash, sufficient to fund the ongoing VANISH trials past top-line results.

"We will continue to operate thoughtfully to progress the development of ibrexafungerp across multiple indications and to opportunistically explore commercial partnerships and other non-dilutive forms of cash injections, like the recent $6.7 million we received from the New Jersey Technology Business Tax Certificate Transfer (NOL) Program," CEO Taglietti said.

The stock gained 9.71 percent to 60 cents in after-hours trading.

FDA Okays Reata's Clinical Trial Design For Phase 3 Study Of Kidney Disease Drug

Reata Pharmaceuticals Inc RETA said it has completed a successful end-of-Phase 2 meeting with the FDA regarding the design of the Phase 3 trial of bardoxolone methyl in patients with autosomal dominant polycystic kidney disease, or ADPKD. The study dubbed FALCON is designed as an international, double-blind, placebo-controlled, parallel group trial, enrolling about 300 ADPKD patients, randomized 1:1 to oral once-daily bardoxolone or placebo.

The primary endpoint is the change from baseline in eGFR, or estimated glomerular filtration rate, compared to placebo after 48 weeks of treatment followed by a four-week withdrawal period.

The company expects to start enrollment in the trial in mid-2019.

The stock gained 2.29 percent to $53.09 in after-hours trading.

Retrophin Gets New CEO

Retrophin Inc RTRX announced the appointment of Eric Dube as president and CEO, effective Jan. 4. He will also join the company's board. Dube will replace Stephen Aselage, who had previously announced his planned retirement after being with the company since 2014.

On The Radar

Earnings

AngioDynamics, Inc. ANGO Q2 EPS $0.22 Up From $0.16 YoY, Sales $91.503M Beat $89.24M Estimate