The Daily Biotech Pulse: EyePoint Licenses Eye Inflammation Drug, Insys Strategic Review Of Opioid Assets, Neos Offering

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

Scaling The Peak

(Biotech stocks hitting 52-week highs on Nov. 5)

• Allakos Inc ALLK
• Allogene Therapeutics Inc ALLO
• Endocyte, Inc. ECYT
• Equillium Inc EQ
• Gritstone Oncology Inc GRTS
• Pacific Biosciences of California PACB
• THERAPIX BIOSCI/S ADR TRPX

Down In The Dumps

(Biotech stocks hitting 52-week lows on Nov. 5)

• Achaogen Inc AKAO(announced plans to explore strategic alternatives and do corporate restructuring)
• Adamas Pharmaceuticals Inc ADMS
• Avadel Pharmaceuticals PLC AVDL (in reaction to its Q3 results)
  REGN's Eylea to treat retinal vein occlusion following failed trial results)
  Cyclacel Pharmaceuticals Inc CYCC
  Foamix Pharmaceuticals Ltd FOMX
  Neos Therapeutics Inc NEOS
  Paratek Pharmaceuticals Inc PRTK
  Unum Therapeutics Inc UMRX
• Checkpoint Therapeutics Inc CKPT
• Clearside Biomedical Inc CLSD(announced intention to discontinue the Phase 3 study that evaluated its Xipere in combo with Regeneron Pharmaceuticals Inc

Related Link: Attention Biotech Investors: Mark Your Calendar For These November PDUFA Dates

Stocks In Focus

Eli Lilly Strikes Partnership to Develop Cancer Drugs

Eli Lilly And CoLLY announced a multi-year collaboration agreement with NextCure for the discovery and development of immuno-oncology therapies using the latter's proprietary FIND-IO platform.

The agreement provides for both companies receiving options to exclusively license antibodies resulting from the collaboration. Eli Lilly would pay NextCure an upfront payment of $25 million, with the latter also eligible for development and commercial milestones and royalty payments. Eli Lilly also made a $15 million equity investment in NextCure.

Eli Lilly rose 2.32 percent to $112.69 in after-hours trading.

Sanofi-Regeneron's Dupixent sBLA Granted Priority Review

Sanofi SA SNY and partner Regeneron said the FDA has accepted the sBLA for Dupixent, with priority review status. The sBLA pertains to evaluation of the drug as a potential treatment option for adolescents with uncontrolled moderate-to-severe atopic dermatitis. The PDUFA date has been set for March 11, 2019.

Eyepoint to License its Drug For Eye Swelling

Eyepoint Pharmaceuticals Inc EYPT and Ocumension announced an exclusive license agreement for the development and commercialization of the former's 3-year micro insert using the Duraset technology for chronic, non-infectious posterior segment uveitis in the greater China territory.

Eyepoint is to receive a one-time upfront payment of $1.75 million from Ocumension, and up to an additional $10 million, if certain development, regulatory and commercial sales and milestones are achieved by the latter.

Eyepoint said it will market its micro insert in the U.S. under the brand name Yutiq.

EyePoint shares rose 4.76 percent to $2.42 in after-hours trading.

Insys To Review Strategic Options For Opioid Assets; Q3 Loss Wider than Expected

Insys Therapeutics Inc INSY said it has initiated a process to review strategic alternatives for its portfolio of opioid-related assets, including Subsys fentanyl sublingual spray as well as formulations of buprenorphine and the combination of buprenorphine/naloxone.

"With a number of clinical and regulatory milestones to achieve over the next few quarters, including the completion of the CBD and epinephrine studies and filing the naloxone NDA, we believe this is the appropriate time to evaluate strategic alternatives for our opioid-related assets," the company said.

Separately, the company reported a decline in its Q3 revenues from $30.7 million a year ago to $18.3 million, with the decline blamed on declines in the TIRF market. The adjusted net loss of 37 cents per share was wider than the 21 cents per share loss expected by analysts.

The stock fell 4.81 percent to $8.12 in after-hours trading.

Neos To Offer Common Stock

Neos commenced an underwritten public offering of its common stock, pursuant to a shelf-registration statement on Form S-3.

The stock declined 10.07 percent to $2.41 in after-hours trading.

Earnings

Mylan NV MYL reported a 4 percent drop in Q3 revenues to $2.86 billion but adjusted earnings per share rose 14 percent to $1.25, coming in ahead of the $1.19 per share consensus estimate. The company also said it is committed to its full-year guidance.

The stock advanced 8.03 percent to $33.89 in after-hours trading.

Infinity Pharmaceuticals Inc. INFI reversed to a profit of 23 cents per share in Q3'18 from a loss of 14 cents per share a year ago, while it reported collaboration revenues of $22 million. Analyst, on average, had expected a loss of 15 cents per share. For 2018, the company said it expects a loss of $10 million to $20 million. The company looks forward to ending the year with cash, cash equivalents and available-for-sale securities balance in the range of $50 million - $60 million.

The stock rallied 9.66 percent to $2.61 in after-hours trading Monday.

PTC Therapeutics, Inc. PTCT reported a wider-than-expected loss of $1.06 per share for Q3. This is despite revenues rising about 28 percent to $53.6 million. The company lowered the high-end of its full-year net product revenue guidance.

The stock retreated 5.86 percent to $35.69 in after-hours trading.

Nevro Corp NVRO reported 16 percent revenue growth to $95.6 million and a loss of 37 cents per share, wider than the 29 cents per share loss expected by analysts. The company lowered its 2018 revenue guidance to the low-end of its previously stated guidance range of $385 million to $389 million.

The stock fell 6.28 percent to $48 in after-hours trading.

On The Radar

Earnings

• ANI Pharmaceuticals Inc Common Stock ANIP (before the market open)
• Eli Lilly And Co LLY (before the market open)
• Becton Dickinson and Co BDX (before the market open)
• BioCryst Pharmaceuticals, Inc. BCRX (before the market open)
• Chimerix Inc CMRX (before the market open)
• InspireMD Inc NSPR (before the market open)
• SAGE Therapeutics Inc SAGE (before the market open)
• Spark Therapeutics Inc ONCE (before the market open)
• Regeneron Pharmaceuticals Inc REGN (before the market open)
• Mallinckrodt PLC MNK (before the market open)
• Neuronetics Inc STIM (before the market open)
• Ironwood Pharmaceuticals, Inc. IRWD (before the market open)
• Ionis Pharmaceuticals Inc IONS (before the market open)
• Haemonetics Corporation HAE (before the market open)
• Eyepoint Pharmaceuticals Inc EYPT (before the market open)
• Adaptimmune Therapeutics PLC – ADR ADAP (before the market open)
• Aquestive Therapeutics Inc AQST (after the market close)
• Accelerate Diagnostics Inc AXDX (after the market close)
• Aclaris Therapeutics Inc ACRS (after the market close)
• Audentes Therapeutics Inc BOLD (after the market close)
• Aerie Pharmaceuticals Inc AERI (after the market close)
• CytomX Therapeutics Inc CTMX (after the market close)
• Iovance Biotherapeutics Inc IOVA (after the market close)
• Theravance Biopharma Inc TBPH (after the market close)
• Cara Therapeutics Inc CARA (after the market close)
• Xenon Pharmaceuticals Inc XENE (after the market close)
• Rigel Pharmaceuticals, Inc. RIGL (after the market close)
• Jazz Pharmaceuticals PLC JAZZ (after the market close)
• Five Prime Therapeutics Inc FPRX (after the market close)
• Genomic Health, Inc. GHDX (after the market close)
• Myriad Genetics, Inc. MYGN (after the market close)
• Halozyme Therapeutics, Inc. HALO (after the market close)
• Inspire Medical Systems Inc INSP (after the market close)
• Paratek Pharmaceuticals Inc PRTK (after the market close)
• Supernus Pharmaceuticals Inc SUPN (after the market close)
• CytomX Therapeutics Inc CTMX (after the market close)
• Immune Design Corp IMDZV
• CymaBay Therapeutics Inc CBAY (after the market close)
• DexCom, Inc. DXCM (after the market close)
• Fulgent Genetics Inc FLGT (after the market close)