Michael Goodman

[Michael Goodman @mikegoodma]

$MTEM ETBs offer a profoundly different MoA than other onco assets. This will be valued by patients who've progressed on, or don't respond to numerous SoCs. The universe of tumors ETBs can go after is vast. They can be used on pts who relapse or are resistant to mAbs/TKIs/I/O etc

[Michael Goodman @mikegoodma]

The investors are reacting to the further pushback of the timeline for readout from the Phase 2a study of elarekibep to mid-2024 from prior guidance of the third quarter of 2023. $PIRS is collaborating with AstraZeneca Plc (NASDAQ: AZN) to develop elarekibep for asthma patients.

[Michael Goodman @mikegoodma]

$TRDA today announced the expiration of the waiting period under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 & closing of the Company’s previously announced strategic collaboration & license agreement with $VRTX. $TRDA will receive an upfront payment of $224M.

[Michael Goodman @mikegoodma]

$BPMC announced that the FDA has accepted its supplemental new drug application seeking label expansion for Ayvakit, Blueprint’s only marketed drug to treat adults’ indolent Systemic Mastocytosis (SM). The FDA has granted priority review to the sNDA with a Prescription Drug

[Michael Goodman @mikegoodma]

ANTI-TIGIT + ANTI-PD-1 BACKBONE

Domvanalimab (AB154): Potential best in class anti-TIGIT monoclonal mAb (mAb; Fc silent) – multiple ongoing Phase 2 and 3 studies enrolling. Zimberelimab (AB122) - Anti-PD-1 mAb; approved in China for classical Hodgkin Lymphoma (cHL).

[Michael Goodman @mikegoodma]

$TRDA today announced a 2nd clinical candidate within its Duchenne franchise, ENTR-601-45, for the treatment of people living with Duchenne who are exon 45 skipping amenable. The Company plans to submit an Investigational New Drug (IND) application in the second half of 2024.

[Michael Goodman @mikegoodma]

$ABBV & $IMNM multi-year collaboration to identify 10 novel target-antibody pairs leveraging Immunome's Discovery Engine. $IMNM to receive $30M payment with potential for further platform access & option payments as well as development, commercial, & sales milestones, & royalties

[Michael Goodman @mikegoodma]

Pfizer Inc, GlaxoSmithKline PLC, Bristol Myers Squibb, AstraZeneca PLC and Sanofi SA plan to raise prices in the US on more than 350 unique drugs in early January. The increases are expected to come as the industry prepares for Biden’s Inflation Reduction Act (IRA).

[Michael Goodman @mikegoodma]

GDA-201 expansion phase will evaluate the safety & efficacy of GDA-201 in 2 patient cohorts, FL + DLBCL/HGBCL. The study will include patients who have relapsed or refractory lymphoma after at least two prior treatments. Please visit https://t.co/HsfRo0mIJb (NCT03019666). $GDMA

[Michael Goodman @mikegoodma]

FDA Reports Allergan's Avycaz Approved!

[Michael Goodman @mikegoodma]

$TRDA today announced that it received a clinical hold notice from the FDA regarding their IND for ENTR-601-44 for the potential treatment of Duchenne muscular dystrophy. https://t.co/FO6huKK575

[Michael Goodman @mikegoodma]

DMD is in 1:3,500-5,000 male births. It affects ~30,000 patients (US & Europe). Exon skipping was approved based on improvement in dystrophin levels ranging from ~1-6%. 40% of patients have mutations amenable to skipping of exons 44, 45, 51 & 53. $TRDA

[Michael Goodman @mikegoodma]

$PFE presents updated favorable Elranatamab data from pivotal P2 MagnetisMM-3 Trial. Data showed high objective response rate of 61% in RRMM patients with no prior BCMA-targeted treatment, with 84% probability of maintaining the response at nine months.

[Michael Goodman @mikegoodma]

Today $GMDA announced the closing of a senior secured convertible term loan of $25 million with certain funds managed by Highbridge Capital Management, LLC.

[Michael Goodman @mikegoodma]

VRTX and $TRDA collaborate to discover and develop EEV Therapeutics for Myotonic Dystrophy Type 1. TRDA to receive $224 million upfront payment & $26 million equity investment and potential milestone payments and royalties. Global collaboration includes ENTR-701.

[Michael Goodman @mikegoodma]

$ABBV will report data from its migraine portfolio at the 16th European Headache Federation Congress (Vienna, Austria) Dec 7-10. At the meeting they will present data from the Chronic Migraine Epidemiology & Outcomes, evaluating neck pain w headache in people w & without migraine

[Michael Goodman @mikegoodma]

$BPMC has submitted a supplemental new drug application to the FDA for label expansion of Ayvakit. BPMC is seeking approval for Ayvakit for treatment of adults with indolent SM, a rare disease. This marks the first regulatory submission for the given indication.

[Michael Goodman @mikegoodma]

As part of its BLA review, FDA issued an information request and viewed the data in the response as a major amendment, resulting in an extension of the omidubicel PDUFA date from Jan 30, 2023 to May 1, 2023. The agency also rescheduled $GMDA Cell’s late-cycle meeting to 1Q23.

[Michael Goodman @mikegoodma]

@nomlastew Nope

[Michael Goodman @mikegoodma]

$GMDA net loss for the third quarter of 2022 was $17.8 million, compared to a net loss of $23.2 million in the third quarter of 2021. As of Sept 30, 2022, Gamida Cell had total cash, cash equivalents and investments of $61.3 million.

[Michael Goodman @mikegoodma]

$MTEM revenues for 3Q22 were $4.2 million, compared to $2.4 million for 3Q21; they were comprised of cash from research & development agreements with $BMS. R&D expenses for 3Q22 were $22.0M, compared with $22.9M for the same 3Q21. As of 9/30/22, MTEM’s cash was $79.4M.

[Michael Goodman @mikegoodma]

$GMDA presented new data: new three-year follow-up data from the Phase 3 study that demonstrated that patients treated with omidubicel had an overall and disease-free survival rate of 63% and 56% at three years, respectively.