The Week Ahead In Biotech: JPMorgan Healthcare Conference, FDA Panel Reviews Opioid Pain Drugs, I-Mab’s IPO

Activity in the biotech space is likely to pick up this week. Events are likely to be headlined by the annual JPMorgan Healthcare Conference.

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Biotech stocks closed 2019 with gains, although they underperformed relative to the broader market. The iShares NASDAQ Biotechnology Index (NASDAQ: IBB) closed up 25.2% in 2019 compared to the S&amp;P 500’s 29% jump.” data-reactid=”19″>Biotech stocks closed 2019 with gains, although they underperformed relative to the broader market. The iShares NASDAQ Biotechnology Index (NASDAQ: IBB) closed up 25.2% in 2019 compared to the S&P 500’s 29% jump.

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="The new year is likely to bring several challenges for&nbsp;biotech stocks, the chief among them being a hard political stance on drug pricing ahead of the year’s elections.” data-reactid=”20″>The new year is likely to bring several challenges for biotech stocks, the chief among them being a hard political stance on drug pricing ahead of the year’s elections.

The following are key catalysts that could take the spotlight this week.

Conferences

38th Annual JPMorgan Healthcare Conference: Jan. 13-16 in San Francisco, California.

Adcom Meetings

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="A joint Tuesday&nbsp;meeting of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee will discuss Nektar Therapeutics’ (NASDAQ: NKTR) NDA for oxycodegol, a NME full mu-opioid receptor agonist, for the management of chronic low back pain in adult patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment.” data-reactid=”25″>A joint Tuesday meeting of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee will discuss Nektar Therapeutics’ (NASDAQ: NKTR) NDA for oxycodegol, a NME full mu-opioid receptor agonist, for the management of chronic low back pain in adult patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment.

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="The same committees on Wednesday will discuss IntelliPharmaCeutics International Inc.’s (OTC: IPCIF) NDA for an extended-release oral tablet formulation of oxycodone. The investigational candidate is being evaluated for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time” data-reactid=”26″>The same committees on Wednesday will discuss IntelliPharmaCeutics International Inc.’s (OTC: IPCIF) NDA for an extended-release oral tablet formulation of oxycodone. The investigational candidate is being evaluated for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="The Anesthetic and Analgesic Drug Products Advisory Committee on Thursday will review DURECT Corporation’s (NASDAQ: DRRX) NDA for bupivacaine extended-release solution for the proposed indication of post-surgical analgesia.” data-reactid=”27″>The Anesthetic and Analgesic Drug Products Advisory Committee on Thursday will review DURECT Corporation’s (NASDAQ: DRRX) NDA for bupivacaine extended-release solution for the proposed indication of post-surgical analgesia.

Clinical Readouts

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Cyclerion Therapeutics Inc (NASDAQ: CYCN) is likely to release Phase 1 data for IW-6463 from the study of healthy volunteers at the JPMorgan Healthcare Conference. IW-6563 is a brain-penetrant,&nbsp;oral&nbsp;sGC stimulator being evaluated for neurodegenerative diseases.” data-reactid=”29″>Cyclerion Therapeutics Inc (NASDAQ: CYCN) is likely to release Phase 1 data for IW-6463 from the study of healthy volunteers at the JPMorgan Healthcare Conference. IW-6563 is a brain-penetrant, oral sGC stimulator being evaluated for neurodegenerative diseases.

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="AzurRx BioPharma Inc (NASDAQ: AZRX) will present new data from five patients enrolled in its Phase 2 study for its lead development candidate MS1819-SD, which is being evaluated as an add on therapy for severe exocrine pancreatic insufficiency, at the 2020 Biotech Showcase Conference being held in San Francisco. The presentation is scheduled for 6 p.m. ET Monday.” data-reactid=”30″>AzurRx BioPharma Inc (NASDAQ: AZRX) will present new data from five patients enrolled in its Phase 2 study for its lead development candidate MS1819-SD, which is being evaluated as an add on therapy for severe exocrine pancreatic insufficiency, at the 2020 Biotech Showcase Conference being held in San Francisco. The presentation is scheduled for 6 p.m. ET Monday.

IPOs

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="I-Mab, a China-based clinical-stage biopharma company focused on the development of biologics, primarily for cancers and autoimmune disorders, has filed to offer 7.41 million ADSs representing 17.04 million ordinary shares in an IPO.” data-reactid=”32″>I-Mab, a China-based clinical-stage biopharma company focused on the development of biologics, primarily for cancers and autoimmune disorders, has filed to offer 7.41 million ADSs representing 17.04 million ordinary shares in an IPO.

The offering is expected to be priced between $12 and $15 per ADS. The company has applied for listing its ADSs on the Nasdaq under the ticker symbol “IMAB.”

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