Mandy Jackson

I am Managing Editor, US Commercial News, for the Citeline Commercial publication Scrip. Views expressed here are strictly my own.

[Mandy Jackson @ScripMandy]

$SRPT’s Phase III ENVISION trial of Elevidys in non-ambulatory DMD patients will not be restarted due to the lengthy pause in enrollment, but cohort 8 in the Phase I ENDEAVOR trial is evaluating prophylactic sirolimus with Elevidys in non-ambulatory patients.

[CureDuchenne @CureDuchenne]

Sarepta shares updates with the Duchenne community, including decision to close the ENVISION gene therapy clinical trial.

Read more by clicking below:

https://t.co/NEHqmhlqXw

[Mandy Jackson @ScripMandy]

Post-election euphoria vanished quickly - $XBI down more than 6% after closing up 2.7% yesterday. Does this mean the hope for more stability for biopharma has gone away or is this just spillover from big tech/AI crashing stocks more generally?

[Mandy Jackson @ScripMandy]

I agree with @RepScottPeters: No data centers on prime, central, downtown-adjacent property in San Diego. The region needs more housing, including affordable options, for people who work downtown and at nearby Navy bases - not noisy, energy-sucking data centers.

[Rep. Scott Peters @RepScottPeters]

San Diego is in a housing crisis. For years, I’ve said that the NAVWAR campus is one of our best chances to build affordable housing at scale.

Last week I strongly, publicly opposed the plans for a data center here. It wastes a chance to provide more housing or something else that benefits the community.

[Mandy Jackson @ScripMandy]

$GILD Paying PepStar Therapeutics $1.275bn up front for a Phase I oral IL-23 inhibitor.

[Gilead Sciences @GileadSciences]

#GileadNews: Today, we announced an agreement to acquire an investigational oral peptide IL-23 receptor inhibitor program. Learn more: https://t.co/6ymBMyVwPN

[Renaissance Capital @IPOtweet]

Allergy and autoimmune biotech Lycia Therapeutics sets terms for $250 million IPO $LYCA $IPO #IPO https://t.co/hpgJHZc1S1

[Renaissance Capital @IPOtweet]

siRNA biotech ADARx Pharmaceuticals prices upsized IPO at $17, the high end of the range $ADRX $IPO #IPO https://t.co/kEhiLwGQ0s

[Mandy Jackson @ScripMandy]

This makes sense given $LLY’s past experience in bone health with Forteo and the potential for GLP-1 drugs to improve health for women with PCOS/PMOS.

[Madison Muller @g0ingmad]

Scoop: @EliLillyandCo has been laying the groundwork for a broader move into women’s health, assembling experts and hunting for new medicines across conditions including bone health and endometriosis.

For @business: https://t.co/GhXp98XSBY

[Renaissance Capital @IPOtweet]

SPAC Allarity Acquisition files for a $100 million IPO, targeting life sciences and biotech $ALLNU $IPO #IPO https://t.co/yxsIDjLyDL

[Mandy Jackson @ScripMandy]

Breaking FDA news from @PharmaPinkSheet

[Sue Sutter @PinkSheetSutter]

US FDA’s Davis, Mikhail Gain Permanent CDER, CBER Director Positions https://t.co/4D4bIDzn0l

[Mandy Jackson @ScripMandy]

A quick take from me (subscription required) on the $NVS $IONS Phase III data for Lp(a) inhibitor pelacarsen. Perhaps more to come from the Scrip team after the Labor Day weekend. https://t.co/bXyEE6iZV7

[Mandy Jackson @ScripMandy]

Interesting thoughts on $NVS $IONS Phase III failure for Lp(a) inhibitor pelacarsen (Scrip story coming soon)

[Ethan J. Weiss @ethanjweiss]

Also this could be 1) that this was the worst of the Lp(a) directed therapies or it could be 2) that showing an improvement in ASCVD risk by lowering Lp(a) in patients aggressively treated to very low LDLc levels is not possible or 3) genetics were wrong and liek HDL, Lp(a) is a risk marker and not a mediator

[Mandy Jackson @ScripMandy]

Notable that none of these companies involved in today’s MFN deals with the Trump administration are members of the Midsized Biotech Alliance of America, formed to lobby on behalf of mid-sized drug makers on policy issues like MFN. https://t.co/iMT1map2Gd

[Maaisha Osman @MaaishaO]

Alcon, Astellas Pharma, BeOne Medicines, BridgeBio, CSL, Kyowa Kirin, Sun Pharma, Teva Pharmaceuticals, and UCB signs MFN deals: https://t.co/BELWmoG6lT

[Mandy Jackson @ScripMandy]

Jefferies said in a note this morning that they expected $35,000/month while an investor survey showed expectations of $41,800. $RVMD

[Mandy Jackson @ScripMandy]

$RVMD Rasonque (Daraxonrasib) approved in the US and already available for prescribing to metastatic pancreatic cancer patients in the second line (and in 1L if not candidates for multiagent systemic therapy) at monthly WAC price of $39,800. https://t.co/ARosJmh9y9

[Mandy Jackson @ScripMandy]

Spreading fast. We see and smell smoke out here in La Mesa/El Cajon area. Stay safe everyone!

[San Diego County Air Pollution Control District @sdapcd]

***ACTIVE SMOKE ADVISORY***

INCIDENT: Sorrento Fire

AFFECTED AREA: Central San Diego County

AFFECTED COMMUNITIES: Mira Mesa, Miramar, Tierrasanta, areas around Mission Trails Regional Park, College Area

For more information visit, https://t.co/KpTB22WuB0

#SorrentoFire

[Mandy Jackson @ScripMandy]

$REPL Replimune wins US FDA accelerated approval for Tudriqev (vusolimogene oderparepvec) for advanced cutaneous melanoma

[U.S. FDA @FDA]

Today, FDA granted approval to a genetically modified oncolytic viral therapy for adults with resistant advanced melanoma. This approval underscores FDA’s commitment to using every available regulatory tool to help bring meaningful treatment options to patients with serious diseases. https://t.co/OrrDGp3iE9

[Renaissance Capital @IPOtweet]

Cardiovascular diseases biotech Braveheart Bio prices upsized IPO at $18, above the range $BRVE $IPO #IPO https://t.co/7RssMKlIP1

[Mandy Jackson @ScripMandy]

Takeda’s Orzeyful (oveporexton) approved for narcolepsy type 1

[U.S. FDA @FDA]

For the first time, a medicine has been approved for narcolepsy type 1 as a complete disorder — targeting the biology behind it, not just its symptoms.

Narcolepsy type 1 affects ~1 in 2,000 Americans and causes debilitating symptoms that touch every part of daily life. Today's approval means patients now have a therapy that addresses the full constellation of those symptoms.

This treatment received both Breakthrough Therapy Designation and Priority Review — two FDA programs designed to bring transformative medicines to patients faster. https://t.co/3SCFdLB8EP

[Renaissance Capital @IPOtweet]

Immune-focused biotech Attovia Therapeutics prices previously upsized IPO at $17, as expected $ATTO $IPO #IPO https://t.co/WOQoi8hlVT

[Renaissance Capital @IPOtweet]

Metabolic disorders biotech Vogenx sets terms for $75 million IPO $VOGX $IPO #IPO https://t.co/KZzX66AgqN