Professor Oak
@Prof_Oak_
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Biopharma Musings | Genetic Medicine & Rare Disease | Buyside Turned Operator | Not Investment Advice | DYODD
Joined December 2020
$PRME proposing to reprice 8.3M options on the back of a 300%+ bounce from May lows. 850K (~10%) belong to new CEO, who's already >$8M ITM on options granted at his appointment. Still >150 FTEs, no active clinical programs, earliest FIH data in 2027, runway into 1H26. Dunno man
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Nice visual representation of China's current advantage in patient recruitment / trial enrollment. Oncology & Obesity Ph1s & 2s enroll 6-9 months faster in China than in the US. H/t @business
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No idea, but the timing is right. Fundamental overhangs have largely cleared, leaving $RNA a very clean story. (1) $DYN pivot cemented first-in-class status in DM1.(2) Ph3 is v high POS & well-powered for secondaries, likely resulting in a superior label at launch.(3) Non-TfR1.
Pure speculation. $lly plane was in SD recently where $rna is located. $rna rings nasdaq bell yesterday, last chance as an independent company? Again pure speculation. I hope they don’t sell out cheaply, bc I think they got big potential.
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Overall transparency score.o3 verdict: 4 / 10 (≈ “moderate-to-low”). "Across the ~80 CRLs issued 2020-24 that we could pair with a company press-release, sponsors publicly disclosed about one-sixth of the specific deficiencies the FDA spelled out in its letters. That ratio is.
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Asked o3 to download all CRL pdfs and evaluate the transparency from sponsors in public communications associated with CRL relative to stated FDA rationale. Here are the results.
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Love @US_FDA's decision to publish historical CRLs. Acknowledge that CRLs for subsequently approved drugs are far less interesting than those never approved, but still a welcome advance for transparency in drug regulation.
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Flashy headline provokes a visceral reaction from the average biotech lifer, but space-based biomanufacturing / formulation innovation isn’t as crazy as it may seem . Good overview and balanced take published recently on @LifeSciVC’s blog.
Atlas EIR Cody Tranbarger opens up the aperture in a blog that's out of this world: "Boosters and Biologics: Is Space-Based Biomanufacturing Real?".
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“2H” Clinical / Corp. $JNJ TNF / IL-23 DUET IBD Ph2b.$BBIO ‘418 LGMD2i Ph3 IA.$BBIO Encaleret ADH1 Ph3.$TAK Orexin NT1 Ph3.$ALKS Orexin NT1/2 Ph2.$CNTA Orexin NT1/2 Ph2a.$SNY AATD Ph2.$KRRO AATD Ph1/2 FIH.$WVE AATD Ph1/2 MAD.$WVE INHBE Obesity FIH.$JANX PSMA / EGFR Updates.$DNTH.
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4Q Regulatory.$SNDX Revu NPM1 PDUFA (10/25/25).$RGNX RGX-121 MPS II (11/9/25).$ARWR Plazosiran FCS (11/18/25).$ASND TCon CNP ACH (11/30/25).$KURA Zifto NPM1 (11/30/25).$AMGN Uplizna gMG (12/14/25).$CYTK Afi HCM (12/26/25).$BHVN Trilu SCA3 (4Q).
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4Q Clinical / Corp. $AGIO Ph3 SCD.$CGEM CD19 Lupus FIH.$GPCR oGLP1 Ph2b.$ALEC Lato FTD-GRN Ph3.$GOSS PAH Ph3.$ZBIO IgG4-RD Ph3.$NUVL ALK Pivotal.$RNA DM1 / DMD OLE.$DYN Ex51 DMD Pivotal.$SRPT / $ARWR DM1 / FSHD FIH.$ELDN CD40L Transplant Ph2.$MLTX SLK PPP Ph2.$ARGX FcRN LN POC.
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3Q Regulatory.$REPL Melanoma PDUFA (7/22/25).$APLS C3G IC-MPGN (7/28/25).$PTCT Sepi PKU (7/29/25).$REGN Odro FL (7/30/25).$INSM Brenso Bronchiectasis (8/12/25).$RARE MPSIIIA GTx (8/18/25).$PTCT Vati FA (8/19/25).$IONS Doni HAE (8/21/25).$TVTX IgAN REMS sNDA (8/28/25).$CAPR.
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3Q Clinical / Corp. $APGE IL-13 AD Ph2 (Tomorrow).$MLTX SLK HS Ph3.$FULC SCD Ph1b Co3.$ABVX IBD Ph3 Induction.$MBX PTH Ph2.$RARE / $MREO OI Ph3 IA2.$VRDN IgG HV.$COGT ISM SUMMIT.$UPB TSLP CRSwNP Ph2.
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Catalyst calendar in 3Q looking light for me (in terms of events about which I care), but still shaping up to be an exciting, back-weighted 2H25. Here's what's on my radar $XBI $BBC.
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Happy 2H25 to all! . Kick it off with TD Cowen's top Q3 events and expected moves $XBI $BBC
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One of, if not the, most generous teachers and contributors our community has ever had. Someone I only knew as a pseudonym, and yet someone who profoundly shaped my trajectory in this crazy biotech world - and I’m just one of many with the same experience. Rest in Peace.
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