The Daily Biotech Pulse: FDA Nod For ADMA, Regulatory Setback For Apyx, Achieve Life Sciences Smoking Cessation Drug Trial

Down In The Dumps

(Biotech stocks hitting 52-week lows on April 1)

• Cyclacel Pharmaceuticals Inc CYC(reacted to a Phase 1 data for its DNA damage response program with an oral, sequential regimen of sapacitabine and seliciclib as a treatment in patients with BRCA mutant metastatic breast cancer)
• Hoth Therapeutics Inc HOT
• RA Medical Systems Inc RMED

Stock In Focus

Dare Bioscience Shares Regain Compliance With Nasdaq Listing Standards

Dare Bioscience Inc DARE said it has regained compliance with the minimum bid price requirement of the Nasdaq by virtue of its shares trading at $1 per share or greater for 10 consecutive business days.

The stock rallied 8.39 percent to $1.55 in after-hours trading.

Nektar and Partner Vaccibody Report Positive Preclinical Results for Cancer Vaccine

New preclinical data presented by Nektar Therapeutics NKTR and Vaccibody AS at the American Association for Cancer Research, or AACR, showed that its personalized neoantigen cancer vaccine VB10.NEO, combined with NKTR-214, a CD122-preferential IL-2 pathway agonist, produced increased breadth and depth of immune response.

The stock moved up 3.31 percent to $34.34 in after-hours trading.

Achieve Life Sciences' Smoking Cessation Drug Given The Nod By Safety Committee

Achieve Life Sciences Inc ACHV said the Data Safety Monitoring Committee, which met March 28 to conduct its second and final safety review of its ORCA-1 trial concluded there are no safety concerns and the trial should continue for completion as planned.

ORCA-1 is a Phase 2b trial that is evaluating a 25-day treatment course of 1.5 mg or 3 mg doses of its smoking cessation drug cytisinicline using either a declining titration schedule or three times daily dosing.

The company expects to release topline efficacy and safety data from the trial in the second quarter of 2019.

Apyx Withdraws Pre-market Regulatory Filing For J-Plasma Surgical Product

Medical device maker Apyx Medical Corp APYX announced it has voluntarily withdrawn its application for premarket notification 510(k) regulatory clearance of J-Plasma/Renuvion for use in dermal resurfacing procedures. The company said it will continue to work with the FDA for a new 510(k) submission.

Separately, the company released preliminary results, expecting first-quarter revenues of $5.6 million-$5.8 million, above the $5.01 million consensus estimate. It also reaffirmed inline 2019 revenue guidance.

The stock slumped 38.13 percent to $4.30 in after-hours trading.

See Also: Attention Biotech Investors: Mark Your Calendar For These April PDUFA Dates

Aveo's Blood Cancer Therapy Aces an Early Stage Trial

AVEO Pharmaceuticals, Inc. AVEO and partner Biodesix announced positive results from a Phase 1b expansion cohort of ficlatuzumab, a hepatocyte growth factor inhibitory antibody product candidate, which is being evaluated in combination with cytarabine in patients with relapsed and refractory acute myeloid leukemia.

The results presented at the AACR annual meeting showed that out of the 12 patients who received ficlatuzumab and cytarabine at the maximally tolerated dose (20mg/kg of ficlatuzumab on day 1 followed by 2 g/m2 cytarabine daily on days 2-7), six achieved a complete response rate, or CR.

The stock jumped 24.32 percent to $1.38 in after-hours trading.

ADMA Receives FDA Approval For Immunodeficiency Treatment

ADMA Biologics Inc ADMA announced FDA approval for its Asceniv Immune Globulin Intravenous, Human - slra 10% liquid, an intravenous immune globulin drug product for the treatment of Primary Humoral Immunodeficiency Disease, or PIDD, in adults and adolescents. The company said it plans a commercial launch in the second half of 2019.

Novartis' Psoriasis Therapy Approved in China, AveXis Unit to Buy Biologics Manufacturing Unit

Novartis AG NVS announced the China Health Authority NMPA approved its Cosentyx for moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

Separately Novartis' AveXis subsidiary announced an agreement to buy an advanced biologics therapy manufacturing campus in Longmont, Colorado, as it prepares to launch its Zilgensma, which is awaiting regulatory nod for spinal muscular atrophy Type 1, and for future gene therapy treatments in development.

Earnings

Titan Pharmaceuticals, Inc. TTNP reported fourth-quarter revenues of $1.2 million compared to $58,000 in the same period last year. The net loss narrowed from $1.04 per share to 62 cents per share. Analysts had estimated a loss of 31 cents per share for the quarter.

The stock slid 7.07 percent to $1.71 in after-hours trading.

Edap Tms SA EDAP reported fourth-quarter revenues of 13.3 million euros or $15.1 million, up 25 percent year-over-year. The company reversed to a net profit of 1 million euros or $1.2 million from a loss of 0.1 million euros or $0.1 million.

The stock soared 34.78 percent to $4.03 in after-hours trading.

On The Radar

Clinical Trial Results

Actinium Pharmaceuticals Inc ATNM will present Phase 2 data for Actimab-A in acute myeloid leukemia at the International Symposium On Targeted Alpha Therapy.

Presentations at the American Association For Cancer Research annual meeting 2019

Dynavax Technologies Corporation DVAX - Phase 1/2 safety data of DV281 (non-small cell lung cancer)
TrovaGene - Phase 1/2 safety and initial efficacy data of Onvansertib (PCM-075) and Zytiga (prostate cancer)
Clovis Oncology Inc CLVS & Bristol-Myers Squibb Co BMY – Poster presentation of Phase 3 data of Opdivo and Rubraca (first-line maintenance treatment of ovarian cancer)
NewLink Genetics Corp NLNK – Phase 2 data for NLG207 (CRLX101) and paclitaxel (platinum-resistant ovarian cancer)
Jounce Therapeutics Inc JNCE - Phase 1/2 data for JTX-2011 (solid tumors)
CytomX Therapeutics Inc CTMX – already released Phase 1/2 data for CX-2009 (solid tumors)

Earnings

AngioDynamics, Inc. ANGO (before the market open)
Matinas BioPharma Holdings Inc MTNB (before the market open)