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The Daily Biotech Pulse: FDA Thumbs Down For Trevena, Corium To Go Private, Immune Design Discontinues Cancer Vaccine Program

The Daily Biotech Pulse: FDA Thumbs Down For Trevena, Corium To Go Private, Immune Design Discontinues Cancer Vaccine Program

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

Amid the market mayhem, no biotech or medical device companies made it to 52-week highs.

Down In The Dumps

(Biotech stocks hitting 52-week lows on Oct. 11)

  • Aerpio Pharmaceuticals Inc (NASDAQ: ARPO)
  • Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY)
  • Assembly Biosciences Inc (NASDAQ: ASMB)
  • BioSig Technologies Inc (NASDAQ: BSGM)
  • Celldex Therapeutics, Inc. (NASDAQ: CLDX)
  • Clovis Oncology Inc (NASDAQ: CLVS)
  • ContraVir Pharmaceuticals Inc (NASDAQ: CTRV)
  • CytRx Corporation (NASDAQ: CYTR)
  • Elanco Animal Health Inc (NYSE: ELAN)
  • Enzo Biochem, Inc. (NYSE: ENZ)
  • Entegris Inc (NASDAQ: ENTG)
  • Erytech Pharma SA (NASDAQ: ERYP)
  • Genprex Inc (NASDAQ: GNPX)
  • Histogenics Corp (NASDAQ: HSGX)
  • Immune Design Corp (NASDAQ: IMDZ)
  • Jounce Therapeutics Inc (NASDAQ: JNCE)
  • Magenta Therapeutics Inc (NASDAQ: MGTA)
  • Mersana Therapeutics Inc (NASDAQ: MRSN)
  • Miragen Therapeutics Inc (NASDAQ: MGEN)
  • Mustang Bio Inc (NASDAQ: MBIO)
  • Mylan NV (NASDAQ: MYL)
  • Neuronetics Inc (NASDAQ: STIM)
  • Novelion Therapeutics Inc (NASDAQ: NVLN)
  • Nymox Pharmaceutical Corp (NASDAQ: NYMX)
  • OptiNose Inc (NASDAQ: OPTN)
  • Otonomy Inc (NASDAQ: OTIC)
  • Paratek Pharmaceuticals Inc (NASDAQ: PRTK)
  • Portola Pharmaceuticals Inc (NASDAQ: PTLA)
  • Provention Bio Inc (NASDAQ: PRVB)
  • RA Medical Systems Inc (NYSE: RMED)
  • Regulus Therapeutics Inc (NASDAQ: RGLS)
  • RXi Pharmaceuticals Corp (NASDAQ: RXII)
  • Seres Therapeutics Inc (NASDAQ: MCRB)
  • Sienna Biopharmaceuticals Inc (NASDAQ: SNNA)
  • Sierra Oncology Inc (NASDAQ: SRRA)
  • Translate Bio Inc (NASDAQ: TBIO)
  • Unity Biotechnology Inc (NASDAQ: UBX)
  • Vascular Biogenics Ltd (NASDAQ: VBLT)
  • Versartis Inc (NASDAQ: VSAR)
  • Zai Lab Ltd (NASDAQ: ZLAB)

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

Stocks In Focus

Corium To Go Private In A Deal Valued Upto $504 Million

Corium International Inc (NASDAQ: CORI) announced an agreement with private investment firm Gurnet Point Capital, which provides for the latter to acquire the former for $12.50 per share in cash upon closing. Additionally, a contingent value right of $0.50 per share is payable, based on the FDA approving Corium's lead product candidate Corplex Donepezil for the treatment of Alzheimer's disease, prior to March 31, 2020.

The transaction is valued up to $504 million.

The stock jumped 50.42 percent to $12.50 in after-hours trading.

Tetraphase Pharma Commercially Launches In U.S. Antibiotic to Treat Abdominal Infections

Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH) announced the U.S. commercial launch of its Xerava for treating complicated intra-abdominal infections, or cIAI. The wholesale acquisition cost of Xerava is fixed at $175 per day of therapy.

Xerava is a tetracycline class antibacterial indicated for cIAI in patients of 18 years and older. It was approved by the FDA in late August.

The stock rallied 12.13 percent to $2.68 in after-hours trading.

Immune Design to Discontinue Cancer Vaccine Program

Giving a portfolio update, Immune Design said it has decided to discontinue the SYNOVATE Phase 2 trial that evaluated the combination of its cancer vaccine CMB305 and Roche Holdings AG Basel ADR Common Stock (OTC: RHHBY)'s Tecentriq, as it believed the combo isn't likely to show a survival benefit in relapsed synovial sarcoma patients.

However, the company said it will seek external collaborations to explore the continued development of CMB305 in sarcoma.

The company also said it would focus on accelerating and expanding the development of its intratumoral TLR4 agonist G100. The company plans to develop G100 in combination with Merck & Co., Inc. (NYSE: MRK)'s Keytruda in follicular lymphoma patients who have received three prior lines of systemic therapy, while also evaluating G100 beyond late-stage follicular lymphoma.

The stock slumped 49.82 percent to $1.40 in after-hours trading.

FDA Panel Votes Against Approving Trevena's Pain Drug

Trevena Inc (NASDAQ: TRVN) announced FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted 8 against and 7 in favor of approving Oliceridine for the management of moderate-to-severe acute pain in adult patients for whom an intravenous opioid is warranted. FDA is set to announce its verdict on the pipeline candidate Nov. 2.

Briefing document released by the FDA panel Tuesday revealed concerns about Oliceridine.

The stock slipped 19.75 percent to $0.76 in after-hours trading.

AbbVie, Novartis Unit Settle Patent Dispute With Respect to Arthritis Medication

AbbVie Inc (NYSE: ABBV) announced resolution of all intellectual property-related litigation it had with Novartis AG (NYSE: NVS)'s Sandoz unit over the latter's proposed biosimilar Humira product.

The terms provide for AbbVie granting Sandoz a non-exclusive license to its intellectual property relating to Humira beginning on certain dates in certain countries where it has intellectual property. In the U.S., the license period is set to begin Sep. 30, 2023, while in most EU countries, the license will begin Oct. 16, 2018.

In return, Sandoz will pay royalties to AbbVie, acknowledging the validity of the licensed patents. The companies did not disclose the financial terms of the settlement agreement.

AbbVie shares rose 1.43 percent to $92 in after-hours trading.

Iovance Reports Results from End-of-Phase 2 Meeting With FDA, To Sell Shares

Iovance Biotherapeutics Inc (NASDAQ: IOVA) said, following an end-of-Phase 2 meeting with the FDA regarding lead candidate lifileucel, the regulatory body acknowledged that a single-arm cohort as part of C-144-01 could be supportive of initial registration, and conduct of a randomized Phase 3 trial in the patient population being enrolled may not be feasible.

Lifileucel is an autologous cell therapy being evaluated for malignant melanoma and other potential indications.

The agency also granted RMAT designation for advanced melanoma, which vests advantages such as increased access to FDA during development, possibility of getting accelerated approval, and a rolling review of the BLA.

Iovance said it expects BLA submission in the second-half of 2020.

Separately, the company said it plans to sell shares in an underwritten public offering. All the shares are to be sold by the company.

The stock rose 2.31 percent to $10.20 in after-hours trading.

Progenics Advances Prostate Cancer Drug Into Mid-stage Trial

Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX) said it plans to advance I-131 1095, its PSMA-targeted therapeutic into a Phase 2 study.

"I-131 1095 is a small molecule radiotherapeutic designed to selectively bind to the extracellular domain of prostate specific membrane antigen (PSMA), a protein that is highly expressed on prostate cancer cells," the company said.

The stock advanced 5.73 percent to $5.90 in after-hours trading.

On The Radar

Adcom Meeting

The Anesthetic and Analgesic Drug Products Advisory Committee will also review AcelRx Pharmaceuticals Inc (NASDAQ: ACRX)'s NDA for sufentanil sublingual tablets for treating moderate-to-severe acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The committee will look at risk-benefit considerations and also recommend approvability of the candidate. The Adcom meeting is scheduled for Oct. 12.


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