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The Daily Biotech Pulse: J&J Earnings, FDA Nod For Medicinova, Proteon To Explore Strategic Alternatives

Shanthi Rexaline

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 April 15)

  • Amneal Pharmaceuticals Inc (NYSE: AMRX)
  • Biohaven Pharmaceutical Holding Co Ltd (NYSE: BHVN)(the company is said to explore a potential sale )
  • Medtronic PLC (NYSE: MDT)
  • Vermillion, Inc. (NASDAQ: VRML)

Down In The Dumps

(Biotech stocks hitting 52-week lows on April 15)

  • Achaogen Inc (NASDAQ: AKAO)(announced bankruptcy filing)
  • Acorda Therapeutics Inc (NASDAQ: ACOR)
  • Aethlon Medical, Inc. (NASDAQ: AEMD)
  • Assembly Biosciences Inc (NASDAQ: ASMB)(presented interim mid-stage results of its hepatitis B virus treatment candidate ABI-H0731)
  • CELLECT BIOTECH/S ADR (NASDAQ: APOP)
  • Conatus Pharmaceuticals Inc (NASDAQ: CNAT)(announced Phase 2 clinical trial evaluating emricasan in NASH patients with cirrhosis and severe portal hypertension)
  • Fennec Pharmaceuticals Inc (NASDAQ: FENC)
  • Imv Inc (NASDAQ: IMV)
  • Sienna Biopharmaceuticals Inc (NASDAQ: SNNA)
  • Vaxart Inc(NASDAQ: VXRT)
  • Verastem Inc (NASDAQ: VSTM)

See Also: The Week Ahead In Biotech: Conferences, Clinical Trial Readouts, Earnings And IPOs

Stock In Focus Motif Says New Iclaprim Data Shows Comparable Efficacy With Standard-of-care

MOTIF BIO PLC/S ADR (NASDAQ: MTFB) presented additional data for iclaprim at the 28th European Congress of Clinical Microbiology and Infectious Diseases, which showed it had comparable efficacy to vancomycin in treating acute bacterial skin and skin structure infection, or ABSSSI, lesions.

The company also said clearance of bacteremia was comparable in patients treated with iclaprim and vancomycin.

"Iclaprim continues to be active against a variety of antibiotic-resistant pathogens like methicillin-resistant (MRSA), methicillin–susceptible (MSSA) Staphylococcus aureus, and other Gram-positive skin and soft structure pathogens collected during 2017 from Europe and the U.S," Motif said.

Rocket To Offer Shares

Rocket Pharmaceuticals Inc (NASDAQ: RCKT) priced its underwritten public offering of 4.5 million shares at $17.50 per share. The company expects to raise gross proceeds of $78.75 million from the offering. All the shares are to be sold by the company. The company expects the offering to close on or about April 18.

Rocket said it intends to use the net proceeds to fund the development of its pipeline of gene therapies for rare diseases, among other things.

The stock fell 3.47 percent to $17.25 in after-hours trading.

FDA Accepts Novartis' Regulatory Filing For Wet AMD Candidate

Novartis AG (NYSE: NVS) said the FDA accepted the BLA for brolucizumab, codenamed RTH258,for the treatment of wet age-related macular degeneration. The company said it used a priority review voucher to expedite FDA review.

If approved by the FDA, the company expects to launch brolucizumab by the end of 2019.

Merck's Keytruda Tested In Combination With Tessa's Cell Therapy For Cervical Cancer

Merck & Co., Inc. (NYSE: MRK) entered into an agreement with immunotherapy company Tessa Therapeutics to evaluate the latter's armored human papillovirus-specific T cell therapy, or TT12, in combination with the former's Keytruda for treating patients with recurrent or metastatic HPV 16 and 18-positive cervical cancer.

Tessa will conduct a multi-center Phase 1b/2 trial to evaluate the safety and efficacy of the combination.

MediciNova Gets FDA Nod For Proceeding With Late-stage Trial For Neurological Disease Drug

MediciNova, Inc. (NASDAQ: MNOV) said following a review the FDA has determined that the company can proceed with a Phase 2b/3 clinical trial of MN-166, or ibudilast, in amyotrophic lateral sclerosis, or ALS.

If the pivotal Phase 2b/3 trial is successful, the company said the safety and efficacy data will be used to support a NDA filing.

Proteon Explores Strategic Alternatives Following Failed Kidney Disease Trial

Proteon Therapeutics Inc (NASDAQ: PRTO) announced its decision to explore a range of strategic options to enhance shareholder value. The decision follows failed late-stage trial results for the company's investigational candidate vonapanitase, which was evaluated for treating patients with chronic kidney disease undergoing surgical creation of a radiocephalic arteriovenous fistula for hemodialysis.

The company also said it is reducing its headcount and spending in order to preserve its cash resources.

View more earnings on IBB

The stock rose 9.43 percent to 58 cents in after-hours trading.

Biopharmx to Effect Reverse Stock Split

Biopharmx Corp (NYSE: BPMX) said its board has approved a reverse stock split of its common stock at a ratio of 1-for-25. The reverse stock split becomes effective April 25. The stock will trade on a split-adjusted basis on the NYSE American under the existing symbol on April 26.

The stock fell 9.40 percent to 8 cents in after-hours trading.

Morphosys Receives Milestone Payment From J&J Unit For Initiating Guselkumab Clinical Program For Additional Indication

Morphosys Ag (NASDAQ: MOR) said its licensee - Johnson & Johnson (NYSE: JNJ)'s Janssen unit – has expanded the clinical development of guselkumab into familial adenomatous polyposis, or FAP, a disease of the gastrointestinal tract.

The disease is characterized by the early onset of polyps throughout the colon, which if left untreated, may develop into colon cancer.

Janssen, according to Morphosys, has initiated a Phase 1b proof-of-concept trial of the candidate. In connection with the start of the clinical program, Morphosys said it received a milestone payment from Janssen.

"Guselkumab is a human anti-IL-23 monoclonal antibody developed by Janssen that was generated utilizing MorphoSys's proprietary HuCAL antibody technology," Morphosys said.

On The Radar Clinical Trial Readouts

Wave Life Sciences Ltd(NASDAQ: WVE) is due to present new Phase 1 safety and tolerability data for WVE-210201 for Duchenne muscular dystrophy, or DMD, Exon 51 at the 2019 Muscular Dystrophy Association, or MDA, Clinical & Scientific Conference.

Sarepta Therapeutics Inc(NASDAQ: SRPT) will present data on MYO-1 for DMD – LGMD2E at the 2019 MDA Clinical & Scientific Conference.

Novavax, Inc.(NASDAQ: NVAX) will present at the World Vaccine Congress, or WVC, already-released Phase 3 top-line data for RSV vaccine in healthy pregnant women to protect infants via maternal immunization. The data released in late February showed that the primary endpoint was not met.

Altimmune Inc (NASDAQ: ALT) is due to present already-released additional Phase 2 data for its flu vaccine candidate NasoVAX at the WVC.

ContraFect Corp(NASDAQ: CFRX) will present new Phase 2 data for CF-301 in treating serious infections caused by Staphylococcus aureus, including MRSA, at the European Congress of Clinical Microbiology & Infectious Diseases, or ECCMID.

SCYNEXIS Inc(NASDAQ: SCYX) is scheduled to present interim Phase 3 open label data for SCY-078, oral, in invasive candidiasis at the ECCMID Tuesday, April 16.

Earnings

Johnson & Johnson Q1 Adj. EPS $2.1 Beats $2.08 Estimate, Sales $20.02B Beat $19.63B Estimate; Raises FY19 Adj. EPS Guidance From $8.65-$8.80 To $8.73-$8.83 vs $8.58 Est., Raises Sales Guidance From $81.6B-$82.4B To $82.0B-$82.8B vs $81.05B Est.

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